HOW THE USE OF INTEGRATED HEALTH INFORMATION TECHNOLOGYEFFECTS THE PATIENT-PROVIDER RELATIONSHIP

By

Timothy E. Greiner

A Capstone Project Submitted to the Faculty of

Utica College

May 2015

in Partial Fulfillment of the Requirements for the Degree of

Master of Science inCybersecurity

© Copyright 2015 by Timothy E. Greiner

All Rights Reserved

ii

Abstract

The purpose of this research was to examine how the uses of integrated health technologies have

affected the relationship between the patient and the provider. The relationship between the

patient and the provider has to continue to adapt and change due to the introduction of electronic

health records (EHRs), mobile health devices, and mobile device apps. With the passage of the

American Recovery and Reinvestment Act (ARRA) Health Information Technology for

Economic and Clinical Health Act (HITECH Act), health information technology (health IT) has

increased at a rapid rate. Health technology will also be changing the way in which patients and

providers interact. Through the use of mobile medical apps and mobile medical devices, patients

and other users can proactively self-manage their own health. Interoperability of mobile medical

apps, mobile medical devices, and EHRs will need to be achieved in the future as these

technologies become more integrated into the health care setting. When looking at the

implementation and management of health technologies, such as in Canada, it can help countries

observe plans and regulations that work successfully. This research has determined that proper

health IT regulations and future strategies will be key to a successful future of health IT.

Keywords, Professor Riddell, Cybersecurity Intelligence, health care, HITECH Act, electronic

health records.

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Table of Contents

List of Illustrative Materials.................................................................................................vHow the Use of Integrated Health Information Technology Effects the Patient-Provider Relationship.........................................................................................................................1Literature Review.................................................................................................................5

Electronic Health Records and Health IT......................................................................5Effects on patient-provider relationships....................................................................8

Improvements of EHR.................................................................................................12Improvements on patient-provider relationship........................................................12

Redesign Health IT Infrastructure...............................................................................13Health IT interoperability.........................................................................................13

Mobile Health Technologies........................................................................................15Telemedicine.............................................................................................................16Impact on rural healthcare........................................................................................17How health care providers use mobile devices and apps..........................................17Use of mobile apps by patients and others................................................................19Remote patient monitoring.......................................................................................19

Management of Mobile Medical Apps........................................................................21Types of regulated apps............................................................................................22Types of non-regulated apps.....................................................................................22

Security of Mobile Health Care Devices.....................................................................23HIPAA standards......................................................................................................24

Canadian Health IT Implementation............................................................................26Remote patient monitoring.......................................................................................27Improvements to EHR implementation....................................................................28

Comparison of EHR Adoption.....................................................................................30Mobile Health App Regulation....................................................................................33

Discussion of the Findings.................................................................................................35Future Research and Recommendations............................................................................43References………………………………………………………………………………..44

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List of Illustrative Materials

Figure 1 – How remote patient monitoring devices collect and transfer information…...18

Figure 2 - Predictions of mobile health apps used by doctors in 2015…………………..21

Figure 3 - Canadian report of interest in using digital health services if available...........27

Figure 4 – HIMSS Analytics EMR adoption comparison.................................................32

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How the Use of Integrated Health Information Technology

Effects the Patient-Provider Relationship

Over the past few years, the United States has seen a proliferation of information

technology (IT) and connected devices in society. As of January 2014, according to Pew

Research Center, 90 percent of American adults own a cell phone, 58 percent of American

adults have a smart phone, and 42 percent own a tablet (Pew Research Ceneter, 2014). This trend

is also reflective in the health care industry. The mobile health market is expected to increase by

61 percent to an estimated $26 billion by the end of 2017 (Crespo & McLaughlin, 2013). The

mobile health market refers to the use of mobile technologies, such as smartphones, tablets

computers, applications (apps), and other electronic devices, that are used for the purpose of

communication, providing, receiving, or managing health care (Ventola, 2014).

The increased use of mobile devices in health care has led to the rapid growth of medical

software apps. Mobile apps are software programs that are developed to run on mobile devices

such as tablets and smartphones (Ventola, 2014). Health care providers are able to use apps for

various purposes such as electronic prescribing of medications, diagnosis, medical treatment,

education and references, coding and billing (Murfin, 2013).

The way doctors use connected devices and mobile apps for patient care varies, but

Caradigm statistics show that 69 percent use mobile apps for protected health information (PHI)

of patients, 65 percent for non-PHI, 49 percent for education/training, 42 percent for clinical

notifications, and 39 percent for secure communications regarding patients (Rosin, 2014).

Smartphones and tablets have become the preferred computing devices for health care providers

who need fast access to information at the point of care (Ventola, 2014).

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The use of health information technology (health IT), including electronic health care

records (EHRs), has been increasing at a rapid rate. According to the report given to Congress

from the Department of Health and Human Services (HHS), 59 percent of hospitals and 48

percent of physicians had at least a basic EHR system in place in 2013 (HHS, 2014). The EHR

market in United States is forecasted a growth of 7.1 percent, growing $9.3 billion (Accenture,

2014). In 2009, prior to the adoption of the Health Information Technology for Economic and

Clinical Health Act (HITECH Act), only 12 percent of hospitals in the United States established

a basic EHR system (Office of the National Coordinator for Health Information Technology

(ONC), 2014, “Report to Congress,” para. 4).

The purpose of this research was to examine how integrated health technologies have

affected the relationship between the patient and provider in the health care sector. How have

mobile health technologies effected and changed the way in which a patient manages their

health? How has the relationship between the patient and provider transformed by the use

electronic health records and electronic health technologies? How does the Canada compare with

the United States on implementation and management of electronic health technologies?

While security and privacy are two major concerns when utilizing new information

technologies in health care, understanding how it will change the relationship between patients

and providers should also be a concern. How a patient interacted with their health care provider

for years has now been redefined with the introduction of integrated health technologies. A study

conducted 2013 by the Rand Corporation with support from the American Medical Association

(AMA) on physician satisfaction, suggest that health care providers are finding that EHRs are a

hassle and they take more time away from actually caring for the patients (Brink, 2014). While

other specialties will improve with health IT, there will be many specialties that may fade such

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as a patient-centered connection. Both patients and health care providers have concerns about the

adverse effects EHRs can have on the patient-provider relationship (Kazmi, 2013).

The relationship between the patient and the provider lies at the heart of health care

delivery. Maintaining and improving a strong relationship between the patient and provider is

important to the delivery of care (Kazmi, 2013). Communication skills have been shown to

influence patient satisfaction, which determines the effectiveness of health care delivery.

This is not the first time that new technology in health care has caused concern over

interference with patient-provider relationships. Physicians were concerned that the invention of

the stethoscope would depersonalize care in the 1700s and in the early 1900s doctors were

concerned that the sphygmomanometer would come between the patients and doctors (Bailey,

2011). However, the new technology being developed today will affect the relationship between

the patient and provider even further. EHRs must fit into the patient provider relationship, so the

focus can still be on the patient. According to ENT Today, a publication of the Triological

Society, one of the major ethical concerns about the adoption of EHR is the impact it will have

on the interaction and relationships between patients and providers (Kitsis & Shmerling, 2014).

The presence of a computer and other devices within the exam room can take away the focus

centered on the patient.

Mobile device management systems in health care IT have to be modified to attend to

these changes. In recent years doctors have been increasing their use of EHRs due to government

incentives, but they are also increasing their use of mobile technologies in health facilities.

Securing these devices and the data that they contain is a priority. Not only does this apply to

devices connected to health care networks but there are thousands of mobile device apps that

need to be regulated and managed. Patients and providers will take advantage of integrated

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technologies to improve health care communications, management of health care, health care

services and improve the accessibility of health information.

Internationally, the market for EHR is projected to reach $22.3 billion by the end of 2015.

In 2012 the global EHR market was $18.8 billion (USD) (Accenture, 2014). According to the

same data collected by Accenture, Canada’s EHR market is expected to grow 2.8 percent,

growing to $0.9 billion by the end of 2015, while the United States is forecasted a growth of 7.1

percent, growing $9.3 billion (Accenture, 2014). How does Canada compare with the United

States with the adoption and management techniques with health ITs and EHRs?

Since 2003 Canada Health Infoway published an EHR solutions blueprint. Canada Health

Infoway is a federally-funded organization that is working with the provinces’ government to

help develop, monitor, and enforce the use of information technology in Canada’s health care

system including all EHR, telehealth and telemedicine programs. Telehealth refers “to the use of

electronic information and telecommunications technologies to support long-distance clinical

health care, professional health-related education, public health, and health administration”

(Telehealth, n.d.).

As of October 2014, reported by Nuviun, Infoway has enrolled approximately 12,000

clinicians in jurisdictional EMR programs and 25,000 specialty health care provider clinics

across Canada (Enriquez, 2014). Canada Health Infoway launched other campaigns to ensure

that Canada’s health IT operates with as little complications as possible. The Better Health

Together campaign will highlight those patients who are benefiting from digital health programs

and services. Knowing is Better for Clinicians is an educational campaign that will demonstrate

the benefits of health IT systems and EHR among Canadian clinicians (Enriquez, 2014).

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The market for health IT is expected to grow in the coming years, so it is important to

understand how health IT will be effecting patients and providers. According to a research

published by Accenture, the projected annual growth of the EHR market in the United States of

2015 will increase 7.1 percent and total $9.3 billion (Accenture, 2014). By 2017 it has been

reported by mobile industry analysts at Research2Guidance that 1.7 billion people will have

downloaded health apps. Furthermore, 3.4 billion people will have a smartphone or tablet with

access to mobile health apps while 50 percent of those people will have downloaded mobile

health apps. (Comstock, 2013).

Literature Review

Electronic Health Records and Health IT

In 2009, the Health Information Technology for Economic and Clinical Health Act

(HITECH) was introduced as part of the American Recovery and Reinvestment Act (ARRA)

which is meant to encourage entities in health care to make better use of health IT and EHRs

(ONC, 2014, “Report to Congress”). Congress and President Barack Obama passed HITECH

and ARRA in order to accelerate health IT, by making this technology more efficient and less

prone to error. Health IT’s aim to achieve more efficiency in accessible health information,

improve quality health care given by physicians, increase organization/accuracy, and also

decrease medical errors.

The coordination and implementation of nationwide health IT efforts, is led by the Office

of the National Coordinator for Health Information Technology (ONC). ONC operates and

maintains HealthIT.gov to provide patients and providers on current issues related to health IT.

Although ONC was created in 2004, it was legislatively mandated with the passage of the

HITECH Act of 2009 (ONC, 2014, “About ONC,” para. 1). Located within the U.S. Department

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of Health and Human Services (HHS), both ONC and HHS have the responsibility of advancing

health IT.

Through ONC and HHS, they developed an interoperability roadmap to advance the uses

of health IT. Interoperability in health care describes “the ability of different information

technology systems and software applications to communicate, exchange data, and use the

information that has been exchanged.” (HIMSS.org, 2013) In order to transform health care

delivery to provide better care and in turn make people healthier, advancing health IT

interoperability is key.

In part of the HITECH act, the government allocated $19.2 billion to expand the use of

EHRs and other health care technologies (Berger, Muchanan, Rasouli, & Serafini, 2012). EHRs

are at the forefront of the health IT infrastructure. EHRs and other supporting health technologies

are intended for health care institutions to share medical data, exchange health information, and

access health information much easier.

Under the meaningful use act, the United States government has given financial

incentives to health care providers to use certified EHRs. For health care providers to receive

financial incentives from the Center for Medicare & Medicaid, they must show meaningful use

of EHRs through three stages. Providers must show that they are using certified EHR

technologies that can be measured significantly in quality (American Academy of Physical

Medicine and Rehabilitation [AAPM&R], 2015).

EHRs have begun to replace paper records in all sections of the health care. An EHR is a

comprehensive record of patient’s medical history. This includes but is not limited to contact

information, health care professional visits, insurance information, family history, information on

any diseases or conditions, medications, and records of surgeries or procedures performed. EHRs

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collect, store, and share a patient’s health information. To improve care, the health care industry

has followed the trend of the rest of society by becoming more technologically advanced.

According to a research published by Accenture, the projected annual growth of the EHR market

in the United States of 2015 will increase 7.1 percent and total $9.3 billion (Accenture, 2014).

Significant progress and advancement has been made over the past few years at making

health care delivery system digital. According to the ONC, over one-half of office-based

professionals and more that 80 percent of hospitals are meaningfully using EHRs (ONC, 2014).

The HHS also reported that all 50 states have some sort of health information exchange services

available to support care and half of hospitals are able to electronically search for patient

information from sources beyond their organization or health system (HHS, 2014).

According to the report given to Congress from the Department of Health and Human

Services, 59 percent of hospitals and 48 percent of physicians had at least a basic EHR system in

place in 2013. In 2009, prior to the adoption of the HITECH Act, only 12 percent of hospitals in

the United States established a basic EHR system. There have also been an increased number of

health care providers who have received incentive payments for meaningful use of EHR systems.

As of June 2014, 92 percent of eligible hospitals and 75 percent of eligible professionals received

incentive payments (ONC, 2014).

In today’s health care environment, there are a number of health care providers (e.g.,

hospitals, pharmacies, labs, doctor’s offices) that rely on EHRs and other supporting technology

to deliver your valuable health data. Not only are the health agencies reliant on health

information to provide proper and quality care, but patients want the same access to their

information. New integrated health care information technology has promoted wellness and self-

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care for patients. The use of health IT and EHRs give the ability to monitor health outcome in

real time, despite all the privacy and security concerns.

Adopting EHR and other health IT, does not mean that it will be effective at what is was

intended to accomplish. There are key barriers that EHRs still needs to over-come. There is a

lack of electronic health information consistency and standardization. According to the

Department of Health and Human Services, electronic health information is “inconsistently

expressed through technical and medical vocabulary, structure, and format, thereby limiting the

potential uses of the information to improve health and care.” (ONC, 2014, “Report to

Congress,” para. 5). There is a growing concern of the possibilities that health IT and EHRs will

adversely affect the patient-provider relationship.

Effects on patient-provider relationships. The introductions of integrated health

technologies and EHRs have transformed the way that the patient and provider interact. Patients

are concerned that the increased presence and increase use of health IT will interfere with the

relationship they have with their health care provider. Doctors are concerned that new integrated

health care technologies with interfere with the patient-provider relationship (Lovett, 2014). The

use of EHRs by doctors may also alter human reasoning and decision processes that are involved

with providing health care (Flanagan, Russ, & Saleem, 2014).

EHRs must fit into the patient provider relationship, so the focus can still be on the

patient. According to ENT Today, a publication of the Triological Society, one of the major

ethical concerns about the adoption of EHR is the impact it will have on the interaction and

relationships between patients and providers (Kitsis & Shmerling, 2014). The presence of a

computer and other devices within the exam room can take away the focus centered on the

patient.

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With the adoption of health IT and EHRs, it has put more control in the patient’s hands.

Patients are able to actively engage in their own health care, which will change the patient-

provider relationship to a more patient-provider partnership (Consumer Reports, 2013). The

notion of mutual participation between the patient and the provider is not new. In 1956 Thomas

Szasz and M.H. Hollender proposed the idea of mutual doctor and patient participation in their

work. A contribution to the philosophy of medicine: the basic model of the doctor-patient

relationship. The proposed models of the doctor-patient relationship presented by Szasz and

Hollender in 1956 are still remain appropriate in today’s health care structure.

Szasz and Hollender proposed three models of the doctor-patient relationship. The three

models are activity-passivity, guidance-co-operation, and the model of mutual participation. The

model of mutual participation gives the patient a greater degree of responsibility and emphasizes

the importance of the doctor-patient relationship in the quality of care (Kaba & Sooriakumaran,

2006). Thus, the concept of a mutual patient-provider partnership has merely adopted to fit the

integrated technologies in the health care sector.

A study conducted by the AMA in 2013, many physicians reported that the EHR has

given them less quality time to interact with their patients (Lovett, 2014). “Time spent looking

for information and documenting information in the EHR means time not spent in meaningful

communication, and the presence of the EHR can detract from connecting with patients.”

(Denton, 2014). Patients want to feel valued but physicians are concerned that EHRs can

negatively affect the patient’s experience.

When technology diminishes the patient-provider relationship, it can create future

concerns and issues. If a patient is dissatisfied and feels the provider has spent more time with

technology rather than focusing on them, the patient may not return for future appointments. A

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dissatisfied experience by a patient can ultimately damage the reputation of the health care

provider which will cause a decline in revenue for the provider (Lovett, 2014).

To balance technology and human touch during a patient’s health visit, Mike Lovett, the

executive vice president and general manager at NextGen Healthcare, suggests organizations

evaluate four questions to keep patients center of visit amongst health technologies:

1. What are patient perceptions of the EHR?

2. Does the EHR make patient care processes smoother?

3. Does patient engagement feel authentic?

4. Is the physician involved in EHR design? (Lovett, 2014).

Although integrated health technologies such as EHRs were developed to manage health

information more smoothly, if it is not used properly it can complicate the process. According to

the AMA Journal of Ethics the most common concerns with health care information technology

has more to do with the design principles and implementation, rather than the technology itself.

Knowing the patient’s perceptions of EHR usage can help the health organization locate areas of

improvement. Physicians and other health care providers are the primary users of EHRs but most

are not involved in the design of EHRs. The AMA is responding to physicians’ need for better

designed EHR systems, by issuing eight priorities to improve usability.

With the adoption of EHRs and other telehealth devices the Federation of State Medical

Boards (FSMB) developed a “Model Policy for the Appropriate Use of Telemedicine

Technologies in the Practice of Medicine” and the AMA issued “Coverage of and Payment for

Telemedicine,” as a guideline for state medical boards. Some state medical boards in certain

states have strict in-person requirements to establish a patient-provider relationship, but the

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FSMB and AMA guidelines suggest that a patient-provider relationship can be established via

telehealth technology (Amundsen and Johnson, 2014).

The FSMB realizes the importance of the collaborative effort and relationship between

the patient and the provider has on the health and well-being of the patient. Once a physician

agrees to undertake treatment of the patient, the relationship has been established between the

patient and provider, whether or not they have meet in person. According to FSMB the physician

should be discouraged from giving medical advice and/or care using telemedicine technologies

without:

Fully verifying and authenticating the location and, to the extent possible, identifying the

requesting patient

Disclosing and validating the provider’s identity and applicable credential(s)

Obtaining appropriate consents from requesting patients after disclosures regarding the

delivery models and treatment methods or limitations, including any special informed

consents regarding the use of telemedicine technologies (Federation of State Medical

Boards, 2014).

The FSMB states guidelines for a patient’s medical records. According to FSMB the

medical record should include copies of all patient-related electronic communications, including

patient-provider communication, prescriptions, laboratory/test results, evaluations, past care, and

instructions obtained or produced in connection with utilization of telemedicine technologies

(Federation of State Medical Boards, 2014).

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Improvements of EHR

If the priorities listed by the AMA were implemented, it could translate into more EHR

adoption by doctors and improve relationships with patients. The AMA lists the following as

usability priorities:

1. Enhance physicians’ ability to provide high-quality patient care

2. Support team-based care

3. Promote care coordination

4. Offer product modularity and configurability

5. Reduce cognitive workload

6. Promote data liquidity

7. Facilitate digital and mobile patient engagement

8. Expedite user input into product design and post-implementation feedback.

(American Medical Association, 2014).

Improvements on patient-provider relationship. One solution that will maintain the

best patient-provider relationship and presents the fewest ethical concerns is a listen-now-type-

later approach (Kitsis & Shmerling, 2014). This approach will maintain the best patient-provider

relationship but will require change to the provider’s procedure due to the introduction of health

technologies.

Another solution that has been proposed is to have a medical transcriber alongside the

doctor to document the information provided. Transcribers are trained in medical terminology.

They will record the visit of the patient. Although this proposed solution would maintain the

necessary focus the doctor has on the patient, it will come with more ethical concerns and

problems such as a violation of the patient’s privacy. If this solution was to take place, patients

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may be hesitant to speak of sensitive or embarrassing problems in front of the transcriber (Brink,

2014).

To establish and maintain effective communication between the patient-provider, EHRs

and other health technologies must be redesigned. The design must minimize the disruptions that

occur during the patients’ visit. Patients want to feel understood, valued, and validated during a

health visit. It is important that future physicians and doctors are trained on the use of these new

integrated technologies but also be trained on how to listen to the patient.

David Denton, a board-certified pediatrician and member of American Academy of

Pediatrics, states that if the design of EHR was changed, it can minimize disruption during the

patient’s visit (Denton, 2014). Doctor’s spend too much time looking for charts and relevant

information about the patient scattered throughout the chart. A summary page with pertinent

patient information would save more time for the doctor to listen to the patient.

Redesign Health IT Infrastructure

The U.S. Department of Health and Human Services (HHS) has taken responsibility to

develop a plan to advance connectivity of electronic health information and interoperability of

health IT. Interoperability within the health IT infrastructure will change the effectiveness of

health IT. The plan has been outline in the document Connecting Health and Care for the

Nation: A 10-Year Vision to Achieve an Interoperable Health IT Infrastructure.

Health IT interoperability. Through ONC and HHS, they developed an interoperability

roadmap to advance the uses of health IT. Interoperability in health care describes “the ability of

different information technology systems and software applications to communicate, exchange

data, and use the information that has been exchanged.” (HIMSS.org, 2013). In order to

transform health care delivery to provide better care and in turn make people healthier,

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advancing health IT interoperability is key. Mobile health devices are an integrated part of the

health IT structure and have the ability to communicate with other health devices. Thus,

interoperability in mobile information technology is crucial to the advancement of health IT.

The U.S. HHS and the ONC has taken responsibility to develop a plan to advance

connectivity of electronic health information and interoperability of health IT. The plan has been

outline in the document A 10-Year Vision to Achieve an Interoperable Health IT Infrastructure.

The ONC and HHS drafted a three stage agenda, starting with three-year, six-year, and ten-year

agendas. The three-year agenda is the first step to send, receive, find, and use health information

to improve health care quality (ONC, 2014). To achieve this, HHS and ONC plan to improve

upon the existing health information networks so patients and providers can appropriately make

use of interoperability health systems.

The six-year agenda hopes to enable individuals to actively participate in managing their

care by enhancing interoperability between health IT devices and systems. Through the use of

health IT tools and mobile applications to integrate data contained in EHRs, the ONC and HHS

hope that individuals will set better health goals and meet those goals. The ONC and HHS states

that interoperability will enable individuals to contribute to their EHR for use by care team

members. This includes remote monitoring of health care with interoperability of medical

devices, home monitoring tools, and other health IT (ONC, 2014).

The ten-year agenda plans to have individuals manage health information from their own

electronic mobile devices and share that information across a variety of platforms. The ONC

states, “The nation’s health IT infrastructure will facilitate health improvement through active

individual health management.” (ONC, 2014). By year ten, ONC believes that more advanced

and more functional tools will support future health research and health of the public.

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Looking into the future, by 2024, ONC hopes that individuals, care providers,

communities and researchers should have a large amount of interoperable health IT products and

services (ONC, 2014). By 2017, ONC is considering to promote linking of mobile apps to EHR

systems. Patients will be able to have access and be able to contribute to their EHR as developers

add application interfaces to the EHR systems (Conn, 2014).

The National Institute of Standards and Technology (NIST) is responsible to set the

standards for EHRs under the HITECH Act (Ciampa & Revels, 2014). Defined under the

HITECH Act, NIST works with the health industry to create health IT standards and testing

infrastructure (Brady, 2014). NIST promotes interoperability through testing and their developed

standards. The focus on refining current health IT standards and the development of standards

needed for the future will shape emerging health technologies (Brady, 2014). To ensure the

interoperability of EHR systems, developers use NIST interoperability standard ISO1 V2.1,

which provides specific data and communication format requirements (Ciampa & Revels, 2014).

Mobile Health Technologies

The increased use of mobile technologies has demonstrated the potential for mobile

communications to improve health care services, improve health information accessibility, and

improve communications. According to Manhattan Research/Physician Channel Adoption study

in 2012, 87 percent of doctors were using a smartphone or tablet device in the workplace

(Ventola, 2014). The mobile health market is expected to increase by 61 percent to an estimated

$26 billion by the end of 2017 (Crespo & McLaughlin, 2013).

Mobile health technologies include smart phones, tablets, medical software applications,

social networking applications, and other telecommunication technology. The introduction of

integrated technologies in health care have been developed with the intent to improve quality of

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health, reduce medical errors, broadening the access to health care, and reduce the cost of

interventions (Ventola, 2014).

The introduction of mobile health technologies in recent years has not only given the

patient more control over their personal health but has also challenged the way providers and

regulatory agencies must manage these new systems. Since not all health care for the patient is

given at one location and is often dispersed between multiple locations and systems, it is

important for health care professionals to have collaboration, communication, and security.

Mobility has become an important feature to both patients and providers for the delivery of

health care (Gerogiou, Prgomet, and Westbrook, 2009).

Telemedicine. Telemedicine and telehealth are closely related terms but refer to different

areas of medical technology. Telemedicine has a more narrow scope than of telehealth, and

refers to the use of electronic communications and information technologies to provide services

to patients in distant locations. Telemedicine includes the use of telecommunication technology,

smart phones, mobile devices and wireless tools that are used to improve a patient’s health (The

American Telemedicine Association, 2012).

Telehealth also refers to the use of electronic information and telecommunications

technologies to support long distant care but includes health related education, public health and

health administration (ONC, 2014). According to the American Telemedicine Association both

telemedicine and telehealth are considered to be part of “Patient consultations via video

conferencing, transmission of still images, e-health including patient portals, remote monitoring

of vital signs, continuing medical education, consumer-focused wireless applications and nursing

call centers, among other applications.” (American Telemedicine Association, 2012). Telehealth

plays a vital role in communication between the patient and the provider, especially for rural

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health care, remote patient monitoring, communication between providers and communication

between patient and provider (Lustig, 2012).

Impact on rural health care. There are many benefits in establishing and adapting

mobile health and telehealth management. The advancements of mobile health technologies has

broadened the reach to improve health in the developing world and rural areas. “Evidence-based

models facilitated by these technologies can improve access to and quality of health care across

the geographic and economic spectrum” (Lustig, 2012, p. 15). The Federal Communications

Commission (FCC) established the Rural Health Care Program which consists of three programs:

the Healthcare Connect Fund, the Telecommunications Program, and the Rural Health Care Pilot

Program. These programs are to provide eligible health care providers with telecommunication

services necessary to improve the quality of health care available (FCC, 2015).

Under the Healthcare Connect Fund, Eligible rural health care providers will be able to

receive a 65 percent discount on expenses. Expenses can include telehealth and telemedicine

services/equipment, network equipment, and broadband services. The expansion of telehealth

given under the Rural Health Care Program, will allow patients to access remote patient

monitoring, enhanced exchange of EHRs, connect rural health care providers to medical

specialists at larger health care providers, and connect telehealth applications over the broadband

network (FCC, 2015).

How health care providers use mobile devices and apps. Health care providers use

mobile devices and apps for varies purposes. Mainly providers will use mobile devices and apps

for:

Information and time management

Electronic health record access and maintenance

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Communications and consulting

Reference and information gathering

Clinical decision making

Remote patient monitoring

Medical education and training (Ventola, 2014).

Consumers and health care professionals alike are taking advantage of mobile device

health care management. According to a study conducted by research2guidance, 15 percent of

the mHealth apps are primarily designed for health care professionals (Jahns, 2013). Figure 1

shows the predictions from research conducted by MedData Group on the most used health care

apps by health care professionals in 2015. There were 375 physicians around the United States

that were polled. MedData suggested that the “findings reflect a general sense that health IT

services are picking up steam among doctors, patients, and corporations…” (Huang, 2015).

E-prescribing is predicted to be the most used health care app in 2015 among surveyed

doctors at 50 percent. Use of EHR health apps among doctors is 38 percent.

Figure 1. Doctors predictions for health care app use in 2015. (MedData Group, 2015).

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According to Manhattan Research survey of 3,066 practicing physicians in 2014, more

than one third recommended that a patient use a health app (Comstock, 2014). Data from the

research groups has suggested physicians’ awareness and engagement with mobile tools is on the

rise (Comstock, 2014).

Use of mobile apps by patients and others. Patients, including those interested in

managing their own health, are using health care apps for many different reasons. Health care

apps can fall into different categories such as clinical assistance apps, monitoring apps, reminder

apps, reference apps, health life apps, efficiency/communication apps, general facility

information apps, patient portal apps, specialty apps (Zwerneman, 2014). The top five interests

when downloading and using mobile health apps were released from a study of 1,015 nationally

representative Americans 18 and older by Makovsky/Kelton survey. Interests include 47 percent

tracking diet/ nutrition, 46 percent medication reminders, 45 percent tracking symptoms, and 44

percent tracking physical activity (Pennic, 2015). Mobile Future and Infield Health issued a

report showing that 247 million Americans have downloaded a health app (Spalter, 2014).

Remote patient monitoring. One of the most beneficial and unique uses of mobile

technologies is the remote monitoring of patients by health care providers. Remote monitoring

“is a type of remote health care in which patients use mobile medical devices to share their

condition with care providers.” (Rouse, 2014). For many patients, they require daily monitoring

and daily communication with doctors. Remote monitoring devices and mobile apps can keep

constant monitoring on patients when doctors cannot spend 24 hours a day directly with one

patient.

According to a study done by Kalorama Information, they have predicted that the market

for advanced patient monitoring systems will reach $20.9 billion by 2016 (Lewis, 2012). By

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2018, remote patient monitoring will save the world’s health care systems $36 billion according

to the projection by Juniper Research (Comstock, 2013). Patients who will greatly benefit from

the increase of patient monitoring systems are patients with chronic disease. “The 100 million

Americans with chronic disease account for about 75 percent of health care expenditures”

(Lustig, 2012, p.12). When remote patient monitoring systems are utilized for chronic disease

care management, there has been a reduction of hospital visits, readmissions, length of stay, and

costs; improvement in some physiologic measure; high rates of satisfaction; and better adherence

to medication (Lustig, 2012).

To provide the best quality of care, care should also be monitored even outside of the

doctor’s office. In a 2012 eHealth survey conducted by Ruder Finn found that 33 percent of

patients want their physicians to have access to remote monitoring technologies (Morrissey,

2014). Remote patient monitoring devices will enable the patient to stay connected with their

provider even at home, broadening the patient and provider relationship. According to a survey

of 3,066 practicing physicians in the United States conducted by Manhattan Research, 20 percent

of doctors are engaged in remote patient monitoring. Those doctors who are engaged in remote

patient monitoring, were monitoring an average of 22 patients a month (Comstock, 2014).

Xavier Sevilla, MD and vice president for clinical quality improvement at Catholic

Health Initiatives, states that “when patients are at home they are still our patients, and we are

still responsible for providing care and delivering health to them.” (Morrissey, 2014). Remote

patient monitoring devices can wirelessly transmit patient vital signs such as heart rate,

respiration, ECG, blood pressure, blood glucose, body temperature, body weight, and posture.

An example of how a remote patient monitoring device collects health information on the

patient and then sends that data to the provider is shown in figure 2. The example used in figure

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2 is of ZephyrLIFE home patient monitoring device, BioPatch. The patient being monitored will

wear the BioPatch and other sensors to gather health information. That information will then be

sent to a mobile device with the ZephyrLIFE app, which will then gather and securely transmit

the information where a health care provider will monitor the patient (Zephyr Technology

Corporation, 2015).

Figure 2. Example of how remote patient monitoring devices collect and transfer information. Zephyrlife home.

Management with Mobile Medical Apps

A major part of mobile health technologies includes mobile apps. Mobile apps have given

people the opportunity to manage their own health and wellness, promote healthy lifestyle

choices, and provide access to health information (FDA, 2014). According to the report mHealth

App Developer Economics 2014, published by research2guidance, by the year 2018 half of the

3.4 billion mobile device users will have downloaded mobile health apps.

The emergence of mobile health technologies and mobile apps has created a challenge for

the FDA. The FDA is responsible for oversight of mHealth devices and mHealth apps.

According to a policy adviser to the FDA, the FDA is unable to keep pace with regulating the

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hundreds of mobile medical apps that are produced each month (Barajas, 2014). The FDA states

that a mobile medical app “is a mobile app that meets the definition of a device in section 201(h)

of the FD&C Act and either is intended:

To be used as an accessory to regulated medical device; or

To transform a mobile platform into a regulated medical device” (FDA, 2015).

According to the FDA a mobile app is considered a medical device if that mobile app is

intended for use in performing a medical device functions. As of February 2015, there are 116

apps on the FDA cleared mobile medical applications list (FDA, FDA Examples of MMAs the

FDA Has Cleared or Approved, 2015).

Types of regulated apps. Under current law, the FDA will have regulatory oversight of

mobile apps that are considered medical devices. Such as mobile apps that transform a mobile

platform into a regulated medical device (i.e. electronic stethoscope, electrocardiograph,

accelerometer, monitor electrical activity of brain, measure blood glucose, measure degree of

tremor, analyze eye movements). Mobile apps that connect to an existing device type for

purposes of controlling its operation (i.e. apps that alter function of an infusion pump, apps that

act as wireless remote control devices for computed X-Ray machines, apps that calibrate or

control cochlear implant, apps that deflate or inflate blood pressure cuff). Apps that are used in

active patient monitoring or analyzing patient-specific medical device data is also subject to

FDA regulation (FDA, Mobile Medical Applications, 2015).

Types of non-regulated apps. Mobile apps that are intended for educational and

reference purposes for health care providers and patients are not regulated by the FDA. Mobile

apps that are generic aids (i.e. communication through email, providing maps to medical

facilities, using HIPPA compliant app for secure communications, using mobile platform to

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record audio and take notes). Also apps that perform general office operations in health care

setting (i.e. billing codes, manage doctor shifts, help patients track, review and pay medical bills

online, analyze insurance claims). The FDA does not regulate mobile apps that are not

considered to be a medical device or apps that pose no threat to the users if they fail (FDA,

Mobile Medical Applications, 2015) (Hickey, 2015).

Security of Mobile Health Care Devices

There is a continuing debate over the development of the standards to assure the security

of health data during storage and transmission (Kayl, Luxton, and Mishkind, 2012). The

increased use of integrated health technologies has raised new concerns about security and

privacy of these devices. The communication capabilities, portability, user patterns and

preferences has increased the complexity of protecting patient data (Kayl, Luxton, and Mishkind,

2012). The introduction of mobile health apps has created a new area of mobile health that must

be protected. Health data can be stored, processed and transmitted between patients and multiple

health care providers.

According to ONC, five steps have been outlined to help develop and implement mobile

device policies and procedures to safeguard PHI in health care organizations:

1. Decide – Decide whether mobile devices will be used to access, receive, transmit or store

patients' health information or used as part of your organization's internal networks or

systems.

2. Assess – Consider how mobile devices affect the risks to the health information your

organization holds.

3. Identify – Identify your organization's mobile device risk management strategy, including

privacy and security safeguards.

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4. Develop, Document and Implement – Develop, document and implement the

organizations mobile device policies and procedures to safeguard health information.

5. Train – Conduct mobile device privacy and security awareness and training for providers

and professionals (ONC, Five Steps Organizations.., 2013).

HIPAA standards. Health Insurance Portability and Accountability Act (HIPAA) sets

the standard for protecting sensitive patient data including PHI and PII. Under HIPAA there

are four rules:

1. HIPAA Breach Notification Rule

2. HIPAA Enforcement Rule

3. HIPAA Privacy Rule

4. HIPAA Security Rule (Leyva, 2013).

According to the HHS, under the HIPAA Security Rule, is a set of security standards that

aim to protect health information that is held or transferred in electronic form (HHS, 2003, The

Security Rule, para. 1). There are administrative, physical, and technical safeguards to ensure

that the confidentiality, integrity and security of electronic PHI (HHS, 2003, The Security Rule,

para. 5). To ensure covered entities are compliant, the HIPAA Security Rule requires covered

entities to conduct a risk analysis to identify risks and vulnerabilities (ONC, 2013, Privacy &

Security and Meaningful Use, para. 12).

Under the HIPAA Privacy Rule there are a set of standards to “protect individuals’

medical records and other PHI and applies to health plans, health care clearinghouses, and those

health care providers that conduct certain health care transactions electronically”

(HHS, 2003, The Privacy Rule, para. 1). The goal of the HIPAA Privacy Rule is to ensure that

individuals’ health information is properly protected but also the flow of health information

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needs to provide and promote high quality care (HHS, 2003, Summary of the HIPAA Privacy

Rule, para. 2). Even when using mobile devices, individuals and organizations that meet the

definition of a covered entity and who transmit health information in electronic form, must

comply with the HIPAA rules of privacy and security (ONC, 2014).

In 2013, the Omnibus HIPAA Rule was announced by HHS, to implement a variety of

provisions that the HITECH Act established (HHS, n.d.). Omnibus Rule strengthened privacy

and security protections of health information. HIPAA requires that Covered Entities and their

business associated must protect the privacy and security of PHI.

According to HIPAA certain mobile health apps must be compliant to HIPAA standards

of privacy and security. Mobile apps must be HIPAA compliant if PHI directly identifies an

individual that is or can be transmitted to a covered entity. Any app that is used to record and

share patient information with a covered entity, than it must be HIPAA compliant. Apps that

record user’s weight, access medical reference information, and other apps that do not transmit

PHI may not have to HIPAA compliant (Wang, 2014).

If the mobile health app is required to be HIPAA compliant, the app must:

Encrypt the data that is being stored

Secured access to PHI via unique user authentication

Safety updates to protect from breaches

Option to mobile wipe device if device is lost

Data backup in case of lost device, device failure, and other disaster

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Canadian Health IT Implementation

The United States and Canada have many differences in the way that providers deliver

health care and the way patients receive health care, but how has Canada implemented their

transition to a technological health care industry and the management of EHRs? Leading the

way to develop and implement health IT and EHRs across Canada, is Canada Health Infoway.

Canada Health Infoway is a federally-funded organization that is working with each Territorial

and Provincial government in Canada to help develop, monitor, and enforce the use of health

care information technology. This is including all EHR, telehealth and telemedicine programs in

Canada. Beginning in 2003, Canada Health Infoway published an EHR solutions blueprint.

In 2014, the National Physicians Survey conducted a study of 10,000 physicians from

around Canada. The survey showed that 75 percent of doctors across Canada have reported that

they are using EHRs. The number of doctors who have chosen to go digital has tripled since

2007. According to the same study done by the National Physicians Survey, they found that

those doctors who reported seeing better or much better quality has reached about 65 percent

(The Canadian Press, 2014).

According to Canada Health Infoway, 89 percent of Canadians feel that it is important

that they have full advantage of digital health tools and capabilities personally. Although an

overwhelming majority of Canadians feel it is important to take full advantage of digital health

tools, >90 percent of patients do not have the access to digital health tools (Canada Health

Infoway, Mobile Health Computing Between Clinicians and Patients, 2014). The Conference

Board of Canada says that if patients were able to access health information online it would have

avoided 47 million in-person health care visits.

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The Harris-Decima annual tracking survey in the report Mobile Health Computing

Between Clinicians and Patients, reported on the interest of digital health services of Canadians

if those services were available. Shown in figure 3, 62 percent of respondents would most likely

view their information in EHR if that service was available to them. In addition, 61 percent

would most likely make appointments with health care providers electronically, 59 percent

would send an electronic request for prescription renewal, and 42 percent would consult with

health care providers online (Infoway, Mobile Health Computing Between Clinicians and

Patients, 2014).

Figure 3. Chart showing Canadian report of interest in using digital health services if available

Remote patient monitoring. According to the study, Connecting Patients with

Providers, published by Canada Health Infoway and commissioned to Ernst & Young LLP,

remote patient monitoring is growing in Canada (Canada Health Infoway, Connecting Patients

with Providers, 2014). The study found that approximately 5,000 patients are enrolled in 19

remote patient monitoring programs across seven provinces around Canada. The study also

suggested four success factors within remote patient monitoring program design.

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1. Engagement and collaboration

2. Patient recruitment and retention

3. Benefits measurement

4. Integrate care and care-coordination (Canada Health Infoway, Connecting Patients

with Providers, 2014).

Improvements to EHR implementation. Dr. Jennifer Zelmer, Executive Vice President

of Canada Health Infoway, states that the slow movement of digital health tools to Canadians is

due to getting the basic infrastructure into place. Also organizing how patients will connect with

their doctors and ways doctors will connect with other members of the health care team have

been slow moving. Dr. Zelmer also stated how digital health care is a fundamentally different

way of providing care; it is a big culture change for patients and health care providers (Zelmer,

2015).

There are two reasons why Canada is lacking with the usage of EHRs according to

Medconnex. The Canadian government has not been encouraging practitioners to begin using

EHRs. While some of the provincial governments across Canada have been slow to adopt these

technologies, there are some provincial governments which have been more proactive at

adopting. The other problem is that Canadian “practitioners are entrenched in their opposition to

the usage of electronic health records.” (medconnex, 2013, para. 2).

Dr. Garey Mazowita, the president of the College of Family Physicians of Canada,

suggested how it may not be such an easy transition for doctors who had a paper-based practice

that are moving to a mobile and digital practice (The Canadian Press, 2014). According to the

same study conducted by The National Physicians Survey, 52 percent those doctors who

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adopted EHRs reported technical glitches, 46 percent had compatibility issues with other

systems, and 26 percent complained of firewall or security problems.

In 2014 the Canadian Medical Association released the report, How can Canada Achieve

Enhanced use of EMRs, on methods to which EMRs can be accelerated in Canada. One method

discussed to accelerate use of EMRs in Canada is the pay-for-performance mechanisms such as

the Meaningful Use provisions the United States has used. Canada Health Infoway has invested

to increase the adoption and interoperability of EMRs but “has not yet gone to the extent of

paying for the use of EMRs in a particular fashion or to achieve quality milestones.” (Canadian

Medical Association, 2014).

Conclusions drawn from the Canadian Medical Association states that for the United

States approach to achieving enhanced use of EMRs to be effective in Canada, it must be

adapted for a Canadian context. While there are pro’s and con’s to the use of pay-for-

performance mechanisms, it may not be the right path for Canada to take to accelerate the use of

EMRs. According to the study, pay-for-performance to enhance the use of EMRs has risks:

Cost to the health care systems increase

The impact on other aspects of the health care system not covered by pay-for-

performance provisions

The impact on the morale of the overall care teams, specifically those care providers not

covered by pay-for-performance incentives

The potential to create disparities in a health care system as funds flow to high

performers (Canadian Medical Association, 2014).

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To form the basis of a Canadian EHR system, the C. D. Howe Institute highlighted five

principles. The C. D. Howe Institute is an independent not-for-profit research institute. Their five

steps are

1. Shared electronic records should be regarded as essential to care;

2. Features of electronic records systems that get in the way of effective clinical practice

should be regarded as safety issues that need to be resolved as a priority;

3. Clinicians should have a single point of access to electronic records about patients they

are treating, regardless of where the record was created;

4. Patients and their caregivers should not find relevant data inaccessible, expensive to

access or at risk of loss because of commercial or financial decisions made by EHR

system vendors; and

5. Patients should ultimately be able to access their EHRs online (Protti, 2015).

To raise awareness among Canadian clinicians and patients, Canada Health Infoway has

established two educational campaigns. Knowing is Better for Clinicians was designed

around Canadian clinicians to raise awareness about the benefits of interconnected health

IT systems and EHRs (Enriquez, 2014). Designed around Canadian patients, Canada

Health Infoway created Better Health Together Campaign to raise awareness of the

benefits of using digital health. This campaign features Canadians sharing their stories

about their experience with using digital health (Canada Health Infoway, Better Health

Together, n.d.).

Comparison of EHR Adoption

Healthcare Information and Management Systems Society (HIMSS) Analytics developed

the EMR Adoption Model in 2005 which tracks the adoption of EMR applications within

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hospitals and health systems around the world. HIMSS is a not for profit organization founded in

1961, that focuses on improving health care quality through the use of information technology

(HIMSS, 2014). The HIMSS Analytics EMR Adoption Model is an 8 step process to reach a

total paperless environment for health care providers. The 8 step process allows health care

organizations to analyze their level of EMR adoption and track progress against other

organizations across the country (HIMSS Analytics, 2015).

All providers and organizations are eligible to participate in the HIMSS Analytics annual

study for free. Once the provider has participated, the provider can obtain their EMR adoption

model score and become operational stage by stage working towards the final 7th stage (HIMSS

Analytics, 2015). The stages 0 through 7, cumulative capabilities, and percent of organization

step completion are show in figure 4. Figure 4 compares the EMR adoption model between the

United States and Canada for 2014.

According to the data, 2014 final numbers show that only 3.6 percent of 5,467 US

hospitals in the HIMSS Analytics Database received a stage 7 award, which is complete use of

electronic records. For the same time period, Canada showed only .2 percent of 641 hospitals at

complete electronic records. There are currently 29.5 percent of US hospitals that were in stage 5

at the end of 2014 that take part in the HIMSS Analytics. The majority of US hospitals that take

part in HIMSS Analytics were in stage 5. Stage 5 consists of a closed loop medication

administration, which requires the coupling of data between the different sections of the hospital

to ensure point-of-care patient safety of medication.

During the same time period there were .6 percent of Canadian hospitals that have

reached stage 5. The majority of Canadian hospitals that take part in HIMSS Analytics were in

stage 3, at 31.7 percent. Stage 3 consists of nursing and clinical documentation that is taken

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electronically. Error checking with order entries and access to medical images outside of the

radiology department via the hospitals intranet is also included within stage 3.

Stage Cumulative Capabilities US EMR Adoption Model Canada EMR Adoption Model2014 Q3 2014 Final 2014 Q3 2014 Final

Stage 7 Complete EMR; CCD transactions to share data; Data warehousing; Data continuity with ED, ambulatory, OP 3.40% 3.60% 0.00% 0.20%Stage 6 Physician documentation (structured templates), full CDSS (variance & compliance), full R-PACS 16.50% 17.90% 0.60% 0.60%Stage 5 Closed loop medication administration 29.50% 32.80% 0.60% 0.60%Stage 4 CPOE, Clinical Decision Support (clinical protocols) 14.50% 14.00% 3.40% 3.90%Stage 3 Nursing/clinical documentation (flow sheets), CDSS (error checking), PACS available outside Radiology 23.90% 21.00% 32.10% 31.70%Stage 2 CDR, Controlled Medical Vocabulary, CDS, may have Document Imaging; HIE capable 5.30% 5.10% 29.50% 29.60%Stage 1 Ancillaries - Lab, Rad, Pharmacy - All Installed 2.50% 2.00% 14.60% 14.40%Stage 0 All Three Ancillaries Not Installed 4.40% 3.70% 19.10% 19.00%

n=5,453 n=5,467 n=638 n=641Data from HIMSS Analytics Database 2014

Figure 4. HIMSS Analytic EMR adoption comparison

To solve the issues of low adoption of EHRs in Canada Joe Natale, the chief commercial

officer at Canada’s leading EHR developer Telus, said it should come from the private sector.

Natale says that the provinces in Canada should permit competition to the existing suppliers of

EHR systems. With competition of EHR system developments, it should produce EHRs that will

be more suitable to the users. Natale also suggests that the Canadian government needs to do

more to provide incentives for practitioners to use EHRs, such as meaningful use incentives used

in the United States (medconnex, 2013, para. 6). The provincial governments should also publish

standards to ensure that EHR and other health technologies meet certain requirements.

There are many challenges at adopting an EHR strategy for Canada. According to the

white paper published by Francis Lau, Morgan Price and Jesdeep Bassi, the benefits of EHR will

be dependent on the type of investments made, the system being adopted, the contextual factors

involved, the way these factors interact, and the time for the system to become balanced (Bassi,

Lau and Price, 2014). There is a need for a coordinated EHR strategy in Canada and can be

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formulated according to investment, adoption and value. Investment at the macro level includes

funding programs, health care standards, policy, socioeconomic and political trends should align

closely with EHRs to maximize benefits. An example of these benefits is the meaningful use

incentive program used in the United States.

At the micro level, providers will only adopt an EHR if the system is well designed. The

EHR system must be easy to use but also be easy to learn with continued training and support.

The system must also be secure and reliable. For a successful adoption and implementation into

an organization, it must be well managed and monitored, as it will affect the value of an EHR

system. The people, organization who is adopting the EHR system and all details of the

implementation stage must be coordinated.

According to Bassi, Lau, and Price there are ten EHR implementation steps that are

proposed if Canada were to move forward to develop their EHR strategy. The steps include

“decide on a long-term EHR investment, define EHR value, align the health care reforms, align

incentives, engage stakeholders in aligned projects, adopt national EHR standards, develop

regional data sharing infrastructures, integrate evaluation, build EHR leadership, and invest in 3-

4 short/intermediate term goals.” (Bassi, Lau & Price, 2014).

Mobile Health App Regulation

Mobile health is challenging the effectiveness of health and privacy regulation in Canada

(Hines, 2014). Manufactures and mobile health app developers are having a difficult time

determining the legislation that they must comply to. The rapid expansion of health technologies

has raised new questions for regulators in Canada.

Health Canada is in charge of regulating the medical device industry under the Medical

Device Regulations of the Food and Drug Act (Jeswiet & McAllister, 2003). Under the Food and

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Drugs Act, “software that is intended or represented for the use in the diagnosis or treatment of

an abnormal physical state of a patient meets the definition of a medical device” (Health Canada,

2010). Medical software regulated as a medical device “provides the only means and opportunity

to capture or acquire data from a medical device for aiding directly in diagnosis or treatment of a

patient” and it also replaces a diagnostic or treatment decision made by a physician” (Health

Canada, 2010).

Health Canada regulates medical device software and has issued guidance over class I

and class II software. Class I medical device software is to be used for tasks such as viewing

images, or other real time data, adjunct to the monitoring device itself, for the purpose of aiding

in treatment or diagnosis of a patient. Class II medical device software is an adjunct to another

medical device and is involved in data manipulation, data analysis, data editing, image

generation, determination of measurements, identification of a region of interest in an image, or

identification of results from a monitor that are outside of an established range (Health Canada,

2010).

There are some issues regarding the regulation of medical device software in Canada.

Health Canada regulates medical devices that are imported for sale or sold in Canada. Questions

such as “does the app qualify as a diagnostic device? Could the app can be downloaded for free?

Or, what if the software is hosted by a server in another country?” have risen (Hines, 2014).

To keep up with the increased flow of mobile health apps in the market, health Canada is

working with regulators from the U.S., Brazil, Japan, Australia, China, European Union and

World Health Organization (Sher, 2014). The current regulations create an uncertainty for app

developers and manufacturers on which statutes and jurisdiction they fall under. Furthermore,

certain medical apps used in Canada can be free of regulation, free from licensing requirements,

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premarket approval, mandatory problem reporting and recalls because of loopholes in current

regulations (Hines, 2014).

Discussion of the Findings

The purpose of this research was to examine how integrated health technologies have

affected the relationship between the patient and provider in the health care sector. How have

mobile health technologies effected and changed the way in which a patient manages their

health? How has the relationship between the patient and provider transformed by the use

electronic health records and electronic health technologies? How does the Canada compare with

the United States on implementation and management of electronic health technologies?

Information technology has revolutionized everyday life, even in all aspects of health

care. Since the introduction of the ARRA and HITECH Act in 2009, the health care sector has

evolved technologically in many ways. The health care sector was allotted billions of dollars of

funding to increase the adoption and make better use of health IT. The increased use of

integrated health IT was proposed to transform the way health care is delivered, received and

managed. The delivery of health care is intended to be more efficient and less prone to error. Not

only did health IT and the HITECH Act aim to improve efficiency, quality and safety of health

care. Additionally, to actively engage patients in their health care with increased privacy and

security.

One of the main goals of the HITECH Act was to expand national EHRs. Since 2009 the

percentage of health care providers that have implemented EHRs and health IT has been

increasing steadily. The HITECH Act and ARRA contain incentives to expand and accelerate the

adoption EHRs and health IT, but providers must also meaningfully use these technologies to

receive those incentives. Providers, such as eligible health care professionals and hospitals, were

35

able to receive incentives for achieving meaningful use of EHRs. To receive these incentive

payments, providers must follow through three stages of meaningful use that shows they are

using certified EHR technology efficiently.

Health IT and EHRs have transformed the way in which patients receive care,

communicate and interact with their providers, and even manage their health. Instead of only

communicating at each hospital or office visit, patients and providers now communicate though

information technology. Before the introduction of health IT, effects on communications

between patients and providers were minimal. Face to face patient provider communication has

become less common. Communication between health care providers and the patients will be

increasingly mediate through information technology and electronic devices.

With the many benefits that health technologies offer, there are also adverse effects that

come with them. The introduction of integrated health care technologies has physicians and

patients trying to understand the effects, while invest in EHR systems, patients portals, telehealth

platforms, mobile health, and social media. A main concern among patients and health care

providers is how EHR use will affect their relationship. Both patients and providers often worry

that the EHRs can negatively affect the patient experience and the relationship between them.

Doctors are going to refine their communication skills in order to fit the adoption of EHR and

other supporting technology into their care. Adoption of EHRs must fit in the patient provider

relationship because the relationship effects patient satisfaction which then effects the efficacy of

health care delivery.

There is a great importance on communication and information sharing between

healthcare providers but also between the patient and the provider. In a poorly integrated and

poorly designed health IT system, the effects will be seen with quality of care that the patient

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will receive. During the health visit patients want to feel understood, valued, and validated.

Patients want to feel comfortable expressing their health concerns with their doctor. When a

doctor is more focused on typing in the EHR and reviewing a patients EHR, the patient can feel

disconnected. This often leaves the patient feeling that the provider is not entirely invested to the

needs of the patient.

The health information that is stored in the EHR is essential to the work the physicians

and other health providers. Some physicians can be overwhelmed with the introduction of health

IT and new work load, which often changes how their medical practice conducts business. The

use of EHRs have the potential to store and organize the clinical information for each patient, but

the amount of information and data that needs to be filed can detract from the quality of the visit.

EHRs can take up much of the time and focus of the doctor in the exam room. Time that should

be spent listening and treating the patient is spent imputing and going through the extensive

information contained in the EHR.

Integrated health technologies have put more responsibility in the hands of the patient.

The patient is able to manage their health with more control. The doctors no longer have full

control over how a patient receives healthcare, but ultimately, a good patient-provider

relationship will be more beneficial for the patient’s health. The combination of technology and

health care are operating on the presumption that they will improve health communication,

strengthen healthcare quality, and improve the management of PHI and PII. With the vast

amount of PHI and PII that health technologies store and transmit, it is important for all patients

and providers to be informed of how it can and will affect them going into the future.

The negative perceptions by patients can also result in adverse impacts to the health care

organization. When patients have negative experiences due to EHRs in the exam room and

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doctors centered focus on EHRs, patients may not return or even leave the health organization

for another. Not only is it important for the health of the patient for effective communication

with the provider, but it is also important to the health care organization to ensure effective

communication is being established.

Patient satisfaction is highly influenced and dependent on how skilled the health care

provider is at communicating. When the patient can also effectively communicate their concerns

and issues with their provider, it can create a more satisfying and beneficial experience for all

involved. Both the patient and provider will benefit from effective communication. Mutual trust

and respect between the patient and provider will also create a more beneficial relationship.

The use of and adoption of health IT and EHRs are going to continue to increase over the

next few years due to government incentives. It is important that health care providers realize the

adverse effects that EHRs and other integrated health technologies can have on their

relationships with patients. Once a health care provider can conceive those adverse effects, they

can begin to improve their implementation of EHRs. With many other sectors inside of the

United States moving to a digital architecture, it was inevitable that the health care sector would

soon follow. Healthcare IT will likely be used well into the future, just as other sectors have gone

digital, so the health care sector has to be prepared to manage these systems properly.

The increased use of mobile devices such as, smartphones and tablet computers, have a

major impact on the way in which its users stay connected and manage daily activities. Growing

reliance on mobile devices has altered the way daily activities are now taking place. The

integration of mobile devices into the health care sector, has transformed the way in which a

patient receives, manages and monitors their health. Health care professionals have also made

use of mobile devices in providing health care.

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Mobile devices have become frequently used in the health care setting which has led to

the growth of mobile health apps. Health care technologies and health apps have been

developing at a rapid pace, offering complete and extensive management of health information to

its users. Health care providers are using mobile devices and apps to manage a patient’s health,

monitor a patient’s health, medical education, reference gathering, health record access,

information/time management, creation of mobile health tools, and keep continual

communication with their patients.

Prior to the development and integration of mobile devices and health apps in health care,

communication would only take place through clinical visits, telephone calls, emails, and paper

mail. Health care and health monitoring could only take place from clinical visits. Mobile

devices and the health apps that they run, are enabling a better quality of care for both patients

and doctors. Patients and doctors are in the process of experiencing the innovative ways that

mobile technologies are improving health care and the delivery of health care.

Mobile health apps are helping people a more proactive approach at managing their own

health and wellness, gain access to useful health information, and encourage a healthier life style.

Health apps have inspired people to take more control to monitor and manage their health.

Annually the number of mobile health users has increased. It is expected to reach one billion

users in the coming years. Mobile health technologies are going to continue to have a major

effect on patient health care. Health care professionals and patients alike are now managing

health care with the use of health IT and mobile technologies.

Mobile health apps are a key tool that patients can use to manage their health. Patients

should become aware of the type of apps that are most appropriate for their needs, by doctors

recommending certain types of health apps. It is also just as important that doctors encourage

39

those patients who want to take a proactive role self-heath management with mobile apps. The

partnership between doctors and patients about mobile health apps, can create better use of such

apps. If a patient downloads the wrong app or misuses an app, without doctor recommendations,

the user can be misled about particular aspects.

Mobile health care has also changed the dynamic of remote patient monitoring. Mobile

devices have made it possible for doctors to remotely monitor their patients from a far distance.

The patient can interact and send vital information to their doctor via mobile devices and mobile

health apps. This is a major advancement that can help those patients who have chronic diseases

that require constant monitoring. Monitoring between visits is also important for patient health.

During this interim period, patients may be less focused on their healthcare responsibilities.

Health IT can encourage patients to stay in touch with their doctor and keep up with health

regimens.

Proper security management and regulation of the thousands of mobile apps that can be

downloaded to a mobile device is critical because of the large amounts of PHI and PII that they

can contain. The FDA has oversight of mobile medical apps as a medical device and the apps

that will present a great risk to patients if they fail to work as they were intended. The FDA also

takes oversight of the mobile medical apps that cause mobile platforms to impact the

functionality of traditional medical devices. Multiple countries have seen the complexity with

regulating mobile apps and have been working together to standardize regulation.

While managing health IT, interoperability is a key step that will support the increased

use of health IT. The newly developed standards and guidelines of interoperability by the ONC

and NIST is important for the long term success of health IT. With the many benefits that

modern health IT provides, it has become clear that health IT is going to be continually

40

developed and integrated into the health care architecture. The increased use of mobile devices

and mobile medical apps in health care are also changing the way health care professionals and

patients interact.

With all the health IT that is being developed and integrated into health care every day,

interoperability is going to be key to the success of integrated technologies. Common standards,

common language for communications and common policy will increase the potential of

interoperability. Common standards in health IT will allow important information to be shared

among health care providers and health care providers can easily share that information with

patients, regardless of the app or mobile device.

It is important to look at how other countries are managing and implementing health IT.

While rate of adoption of health IT may happen at different rates for other countries, it can be

beneficial to see the programs that other countries are using to help expand health IT. Each

country has a different form of health care but looking at programs that other countries have

implemented, can give detail of what works within their health care sector. Satisfaction among

doctors and patients can also be seen when looking at such programs. Programs can then be

altered to fit their system.

The programs and rate of which health IT is being adopted in Canada was reviewed in

this paper. Although Canada has not implemented EHRs and digital health tools into their health

care system at the same rate as the United States has, Canada has great potential for increased

adoption. The low adoption rates are due to a lack of basic infrastructure to accelerate the use of

digital health tools. The United States government has encouraged the use of EHRs through

financial incentive programs from the Center for Medicare & Medicaid. The Canadian

government does not offer such a program to encourage the use of EHRs with incentives. The

41

Canadian Medical Association discussed using incentive programs, similar to the United States

approach, in Canada to achieve enhanced use of their EHRs. For the United States approach to

be effective in Canada, it must fit in the Canadian health care architecture.

The Canadian government should provide incentives to health care providers to increase

the adoption of EHR systems. Integrated health IT, including EHRs, are the new innovative ways

to improve the quality of health care. Therefore, it is important for the future of Canadian health

care to successfully implement health IT in the coming years.

The modernization of health care around the United States and Canada relies on the

foundation of health IT. Significant changes to health care have been made with the introduction

of integrated health IT. Although health IT will not eclipse the benefits of doctor visits, it has

drastically affected the way patients communicate, manage health, deliver, and receive health

care. New health IT is being developed at a rapid pace and there will continue to be significant

beneficial uses and challenges associated with the technology. Not only have the delivery of

health care and the management of health care been changed but the relationships between health

care providers and patients have been affected. Health care providers will have to make changes

to their communication techniques to compensate for the presence of EHRs and other health IT

tools. As the adoption of health IT increases, the healthcare sector must focus on interoperability

of health technologies.

Future Research and Recommendations

After discussing the findings of this research, there are other avenues of future research

that can be conducted. The final rule for Meaningful Use stage 3 has yet to be proposed but will

affect the interoperability of health IT, among eligible health care providers that follow the

Meaningful Use policy. Stage 3 plans to further advance the interoperability of EHRs and a

42

range of health IT that will affect how patients and providers connect. New mobile health apps

are being developed that are affecting the connection between patients and providers but also

how a person can self-manage their own health. Further research on those mobile health apps

that have been approved by the FDA should be conducted to look at how it affects both patients

and providers. Research on the effects of quality of care that is provided by mobile health apps

should also be conducted. The quality of care provided from the use of a mobile health app can

then effect the relationship that the patient has with their doctor, relying less on the doctor for

quality care. One should also look at how the growth of cloud computing/storage has changed

the data architecture in health IT and if the cloud has been implemented for the use of EHRs and

health apps.

43

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