Where Health Care and Digital Revolution Intersect

CONSUMER HEALTH INFORMATICS & COMMUNICATION LABORATORY

Where Health Care and Digital Revolution Intersect

disruptive innovation in health care

James G. Boram KimConsumer Health Informatics & Communication (CHIC) Laboratory

Seoul National [email protected]

Mini Nursing Informatics Symposium · Tzu Chi College of Technology, Taiwan · June 26th, 2014

The World has been Changed: Banking

The World has been Changed: Banking

The World has been Changed: Traveling

The World has been Changed: Research

The World has been Changed: Medical Practice

The World has been Changed: Medical Practice

Digital [R]Evolution in Health Care

Health Care Crisis

$0

$325

$650

$975

$1,300

3.5%

4.4%

5.3%

6.1%

7.0%

1991

1992

1993

1994

1995

1996

1997

1998

1999

2000

2001

2002

2003

2004

2005

2006

2007

2008

2009

2010

Taiwan (% of GDP)Taiwan (Expenditure Per Capita)

Not DirectlyRelated

Health Statistics in Taiwan 2010 & OECD Health Statistics 2013

Health Care Crisis

$0

$550

$1,100

$1,650

$2,200

3.5%

4.6%

5.8%

6.9%

8.0%

1991

1992

1993

1994

1995

1996

1997

1998

1999

2000

2001

2002

2003

2004

2005

2006

2007

2008

2009

2010

Taiwan (% of GDP)Korea (% of GDP)Taiwan (Expenditure Per Capita)Korea (Expenditure Per Capita)


Not DirectlyRelated

Health Care Crisis

$0

$2,250

$4,500

$6,750

$9,000

3.5%

7.1%

10.8%

14.4%

18.0%

1991

1992

1993

1994

1995

1996

1997

1998

1999

2000

2001

2002

2003

2004

2005

2006

2007

2008

2009

2010

Taiwan (% of GDP)Korea (% of GDP)U.S. (% of GDP)Taiwan (Expenditure Per Capita)Korea (Expenditure Per Capita)U.S. (Expenditure Per Capita)


Not DirectlyRelated

OECD Average in 20119.3% of GDP

$3,322 Per Capita

The Innovator’s Prescription: Disruptive Innovations

C.M. Christensen, The Innovator’s Dilemma: When New Technologies Cause Great Firms to Fail, 1997

Performance

Time

Sustaining Innovations

Disruptive Innovations

Most DemandingCustomers

Least DemandingCustomers

Business Models in Health Care

Based on Jason Hwang’s Work

Laboratory

ServicesSpec

ialty

Car

e

ImagingServices

Clinical Researchand Training

Data Collectio

n

and Warehousin

g

Surgical Suites

Solution Shops- Fee for Service

• Consulting Firms • High-end Law Firms • R&D Organizations • Diagnostic Activities of Hospitals

Value-addingProcess Businesses- Fee for Outcome

• Retailing • Manufacturing • Food Services • Medical Procedures

FacilitatedUser Networks

• eBay • Insurance • Education • Telecommunication • D-Life (for diabetes patients & families)

- Membership and/or Advertising

• Regulations • Licensure and Accreditation • Cultural Resistance • Payment and Reimbursement

Policies

Do We Need Doctors or Algorithms?

“”

By 2025 more data-driven, automated health care will displace up to 80% of physicians’ diagnostic and prescription work. It will AMPLIFY physicians by arming them with more complete, synthesized, and up-to-date research data, all leading to better patient outcomes.

600,000Pieces of Medical Evidence

1,500,000Patient Records

2,000,000Pages of Text

from 42 Medical Journalsand Clinical Trials VS

90%Successful

Diagnosis Rate

50%Successful

Diagnosis Rate

160Hours of Reading a Week

Just to Keep Up withNew Medical Knowledge

as It’s Published

When the Doctor is Not Needed

Based on a New York Times Editorial Entitled “When the Doctor is Not Needed”

”

Pharmacists

“Pharmacists can start, stop or adjust medications, order and interpret laboratory tests, and coordinate follow-up care.

”

Nurse Practitioners

“Substantial evidence shows that nurse practitioners are as capable of providing primary care as doctors and are generally more sensitive to what a patient wants and needs. ”

Retail Clinics

“The retail clinics treat common conditions like ear infections, administer vaccines and perform simple laboratory tests.

Who is the Real Medical Expert?

“

”

When we say patient-centered medicine, what we usually mean is the contrast between a patient-centered approach versus an approach where the doctor and health system is in the center and the patient is orbiting around. But, I think implicit in most of our words, when we say this, is still the notion that expertise is flowing from the healthcare system to the patient.

Who is the Real Medical Expert?

“”

In many cases, we have patients who are not just experts in what they feel and what they experience, but experts in the science of their disease. […] Patients often become micro-experts on their disease and treatment.

The Rise of e-Patients

Pew Research Center’s Internet & American Life Project, 2013

engaged when they seek to access their own health information

enabled when they have access to their own health information

equipped when they understand their own health information

then empowered to achieve self-management of their care

“ ”You are already your own doctor.

72%of U.S. Internet users say they looked online for health information within the past year

(62% of U.S. adults)

7 10inU.S. adults have tracked a health indicator for themselves or for someone else

Of those, 34% share their health tracking recordsor notes with another person or group

Search: Gets Deeper and More Personalized

Based on Matthew Holt’s Evolving View of a Moving Target

Communities: Providing Support, Answering Questions, Aggregating Data, and Tracking Outcomes


Tools: Unlocking Databases with New Interface and Analytics


Health 2.0: Better Integration of Data with Content

Search

Social Networks

Tools

TransactionData

Content


“ ”All with the result of patients increasingly guiding their own care.

Gimme My “Damn” Data!

OpenNotes: Sharing Clinicians’ Notes with Patients

1.8 millionOver

So Far

92%

Up to

of Patients in OpenNotes Study

OpenedTheir Notes

60%

More than

of PatientsReported Doing Better with

Taking Medications as PrescribedBecause of Open Notes

Data Liquidity: When Data Flows Faster and More Freely

“”

Consumers are managing bank accounts, investments, and purchases on-line, and many turn to the Web for gathering information about medical conditions; they will expect this level of control to be extended to online medical portfolios.

Your Health ScoreEvery area of your life affects your overall health. Your healthscore helps you understand how you’re doing and where there is room for improvement.

72

Completing even the simplest of tasks can improve your overall health

IMPROVE YOUR HEALTH!

Stop smoking for goodLower your blood pressure

+10

Make a medicine planDoing so can lower your risk for heart attack

+5

Schedule your annual physicalMake sure to update your plan of care

+3

Ellen Ross

D.O.B: 03.07.60

Age: 52

Gender: Female

Phone: 816.555.1229

Language(s) spoken: English

Email: [email protected]

Name of Provider: Ashby Medical Center

Address: 1002 Healthcare Dr, Portland, OR 97266

Telephone: 415.555.1200

HEALTH RECORD

Coronary Heart Disease ACTIVE CONDITIONS & TREATMENTS

DIAGNOSIS

Chopidogrel (Plavix)Prevent Blood Clots

Astrovastatin (Lipitor)Lowers Cholesterol

AspirinPrevent Blood Clots

Preventative Medicine Plan

Cardiovascular Rehabilitation (exercise plan)

OUTCOMECholesterol and Hypertension fall within acceptable ranges.

�

OUTCOME

SEPT 26, 2011

Heart attack caused by 100% blockage to right artery.

Cholesterol (Lipid Panel) Test

OCT 26, 2012

Routine Cholesterol (Lipid Panel) Test

ORDERED

PRESCRIBED MEDICINES

LIFESTYLE CHANGES

Daily Cardiovascular Exercise

Low Fat / High fiber diet

Maintain healthy weight

Physician: Dr. Tim Lee Physician: Dr. Tim Lee

LAST OFFICE VISITCURRENT TREATMENT

PAGE 1 OF 2LAST UPDATED NOV 30 2012

It is important to repeat these steps every day to maintain good health.

My Medicine Plan

NAME OF MEDICATIONDAILYTOTAL

Liptor

Enteric-Coated Asprin

Plavix

Toprol

Fish Oil

20 mg

81 mg

75 mg

25 mg

325 mg

--

--

--

--

325 mg

20 mg

--

--

--

325 mg

40 mg

81 mg

75 mg

25 mg

975 mg

BEFORE BREAKFAST WITH LUNCH AT BEDTIME

Lipid Panel (mm/Hg)

MY GOAL

249

60

76

112

95

Below 200

Above 40

Above 130

Below 150

Below 70

225

55

92

124

82

180

45

103

130

68

185

58

132

136

6

Total Cholesterol

HDL

Cholesterol, NON-HDL

Triglyceride

LDL

LAB RESULTSMAY 2012 JUN 2012 JULY 2012 SEP 2012

Body and Test Results

VITALS MY GOAL

115 / 77

78

198

120/80 (resting)

60 - 90 (resting)

150 - 170

116 / 72

72

195

112 / 75

77

192

115 / 73

84

195

Blood Pressure

Heart Rate

Weight

(mg/dL)

(bpm)

(pounds)

MAY 2012 JUN 2012 JULY 2012 SEP 2012

ALLERGIES

SEVERITYREACTIONNAME OF ALLERGY

Bee Stings

Penicillin

Codeine

Anaphylactic Shock

Hives

Shortness of Breath

Severe

Moderate to severe

Moderate

PAGE 2 OF 2LAST UPDATED NOV 30 2012

JU H A N S O NI N

Sonin, Juhan 22 Surry RdArlington, MA 02476617 504 [email protected]

HealthCard

LANGUAGE MARITAL STATUS RELIGION

English Married Atheist

VISION ALERGIES MEDICATIONS VISION

20/15 None None 20/15

HEALTHPLAN

Harvard PilgrimPOLICY NUMBER

H468798902

1972.022.64.7489.JPS

SEX

MHGT

5-10WGT

199 lbsDOB

1.Mar.1972, 40yo

GUARDIAN CONTACT Kate Sonin Same address 617 548 [email protected]

PRIMARY CARE PHYSICIANDavid Ives, MD781 672 2250

VACCINATIONSTetanus Hepatitis B TyphoidTB Diphtheria MeningealMMR Influenza SmallpoxHepatitis A Polio Yellow Fever

United States of America

A+

84

Blood Pressure

GlucoseHDL

LDL

Triglycerides

Sleep

Happiness

Weight

Alcohol, Drugs

Environment

Medications

Exercise

Nutrition

Waist Circumference

Vaccinations

DiabetesMonitor Blood Sugar, Take Insulin 3x daily

CONDITIONS

High Blood PressureExercise 1hr day to reduce weight and waist circumference.

Lose 10 poundsEat 700 less calories/day. Reduce saturated fat to 16 grams/day.

Torn bicep procedureKeep thumb straight continually by splint and tape until 24.May.

Next Appointment 12.May.2013, Check-up Data current as of 29.Nov.2012

WEIGHT

199 lbs

GLUCOSE

101 mg/dl

HDL

35 mg/dl

WAIST CIRCUMFERENCE

34 inBLOOD PRESSURE

117/79 mmHg

LDL

128 mg/dl

Quantified Self: Self Knowledge through Self-tracking



Self-experimentation: Single-Subject (“N-of-1”) Trial

UsualCare

100 People 50 People

Symptoms

Symptoms

ExperimentalTreatment

50 People Population

Based on Ida Sim’s Work


UsualCare

100 People 50 People

Symptoms

Symptoms


50 People Population

Me

Individual

UsualCare


UsualCare


Symptoms Symptoms

UsualCare


Based on Ida Sim’s Work


Seth Robert measured his arithmetic speed daily:how fast he does simple arithmetic problems, such as 3+4

Several years ago, he discovered that butter — more precisely, substitution of butter for pork fat — made him faster.

Patient Self-Care: Home Hemodialysis

Based on Joseph Cafazzo’s Work



Improved Health Outcomes Cost-Effective ModalityPatient Autonomy



Cost-Effective ModalityPatient Autonomy

Normalization of Blood Pressure without the Need for Anti-Hypertensive Medications

Normalization of Abnormal Wall Thickness of the Heart

Restoration of Impaired Heart Function

Improvement in Peripheral Circulation

Improvement in Sleep Quality

Improvement in Nutritional Determinants

Elimination of Dietary Restriction

Improved Health Outcomes

Patient Self-Care: Do-It-Yourself Hemodialysis

“

”

As long as you have a high school degree, understand the principle of dialysis, follow the operational instructions and keep a close watch during the process, nothing should go wrong. […] The most important part of the machine is the filter, and I can use each one eight times. A new filter costs $17, while a proper medical machine can run into hundreds of thousands of dollars. […] When I told the doctors what I was doing, they said I was crazy.

Peer-to-Peer Health Care: Patients Like Me

1 5in

U.S. Internet users have gone online to find others like them

People living with chronic and rare conditions are significantly more likely to do this.

Pew Research Center’s Internet & American Life Project, 2011

“”

What is extremely difficult about having a kid with Kawasaki disease, before the diagnosis, is just the not knowing.

Peer-to-Peer Health Care: Patients Like Me

Lithium delays progression of amyotrophiclateral sclerosisFrancesco Fornai*†‡, Patrizia Longone§, Luisa Cafaro†, Olga Kastsiuchenka*, Michela Ferrucci*, Maria Laura Manca¶,Gloria Lazzeri*, Alida Spalloni§, Natascia Bellio!, Paola Lenzi*, Nicola Modugno†, Gabriele Siciliano¶, Ciro Isidoro!,Luigi Murri¶, Stefano Ruggieri†, and Antonio Paparelli*

*Department of Human Morphology and Applied Biology, and ¶Department of Neuroscience, Clinical Neurology, University of Pisa 56100 Pisa, Italy;†Istituto Neurologico Mediterraneo, Istituto Di Ricovero e Cura a Carattere Scientifico Neuromed, 86077 Pozzilli (IS), Italy; §Molecular Neurobiology Unit,Santa Lucia Foundation, 00179 Rome, Italy; and !Department of Medical Sciences, University of Novara, 28100 Novara, Italy

Edited by Thomas C. Sudhof, University of Texas Southwestern Medical Center, Dallas, TX, and approved December 21, 2007 (received for reviewAugust 24, 2007)

ALS is a devastating neurodegenerative disorder with no effectivetreatment. In the present study, we found that daily doses oflithium, leading to plasma levels ranging from 0.4 to 0.8 mEq/liter,delay disease progression in human patients affected by ALS. Noneof the patients treated with lithium died during the 15 months ofthe follow-up, and disease progression was markedly attenuatedwhen compared with age-, disease duration-, and sex-matchedcontrol patients treated with riluzole for the same amount of time.In a parallel study on a genetic ALS animal model, the G93A mouse,we found a marked neuroprotection by lithium, which delayeddisease onset and duration and augmented the life span. Theseeffects were concomitant with activation of autophagy and anincrease in the number of the mitochondria in motor neurons andsuppressed reactive astrogliosis. Again, lithium reduced the slownecrosis characterized by mitochondrial vacuolization and in-creased the number of neurons counted in lamina VII that wereseverely affected in saline-treated G93A mice. After lithium ad-ministration in G93A mice, the number of these neurons washigher even when compared with saline-treated WT. All thesemechanisms may contribute to the effects of lithium, and theseresults offer a promising perspective for the treatment of humanpatients affected by ALS.

autophagy " clinical study " G93A mice " morphological analysis

ALS is a devastating neurodegenerative disorder with noeffective treatment that usually leads to death within 3–5

years from diagnosis (11 months for the bulbar form) (1). ALSoccurrence is primarily (90%) sporadic, while only 10% isfamilial (fALS). Approximately 20% of fALS are due to muta-tions of the gene coding for the enzyme copper–zinc superoxide-dysmutase (SOD1) (2). Transgenic mice over expressing thehuman mutant SOD1 develop a pathology that is very similar tothat seen in ALS patients [see supporting information (SI) Textfor a comparison]. Studies in animal models or in vitro led to theidentification of a variety of alterations in ALS motor neurons(MN) (1, 3, 4); however, other cells in the spinal cord besides MNare affected (5–8). For instance, a class of interneurons dieeither before or concomitantly with MN, as found in mice (9, 10)and postulated in humans for Renshaw-like cells (11). Again,glial cells participate in the deleterious interplay leading to MNdegeneration (6–8).

After the generation of the SOD1 ALS mouse models,attempts have been made to find effective treatments. However,so far, none of these trials has led to effective clinical outcomes.

Lithium is a compound used as a mood stabilizer, which isneuroprotective in a variety of disease models (12, 13), such asbrain ischemia (14) and kainate toxicity (15). The ability oflithium to promote autophagy, through the inhibition of theinositol-monophosphatase 1 (16–18), together with the protec-tive effects of autophagy in neurodegeneration (19–22),prompted us to test the neuroprotective effects of lithium in the

G93A ALS mouse model. Based on the promising data, weobtained in mice we quickly moved into a clinical trial, which isnow at the end of its second year.

ResultsEffects of Lithium on Disease Duration and Survival in G93A Mice.G93A male mice were treated daily with lithium carbonate (1mEq/kg, i.p.), starting at 75 days of age. Lithium treatmentprolonged the mean survival time from 110.8 ! 5.0 days (n " 20)to 148 ! 4.3 (n " 20, #36% of the life span of these mice; Fig.1a; P $ 0.001) and, most importantly, increased disease duration(from a mean of 9 days to %38 days, %300%; Fig. 1b; P $ 0.05)compared with the G93A mice treated with saline. Even whenlithium treatment was started at the onset of motor symptoms,the increase in disease duration was still comparable (data notshown). More specifically, lithium delayed the onset of paralysisand limb adduction (Fig. 1c) and significantly improved addi-tional tests we report in SI Fig. 6, such as rotarod, grip strength,and stride length.

Effects of Lithium Treatment on Motor Neuron Survival (Lamina IX ofLumbar and Cervical Spinal Cord and Brainstem Motor Nuclei). Theseeffects were accompanied by a reduced loss of lumbar MN at 90days of age (SI Fig. 7). However, at the end of disease (whichoccurred later following lithium), the number of alpha-MNwithin lumbar lamina IX of the G93A mice treated with lithiumwas comparable to that found in the saline-treated mice that haddied previously (SI Fig. 8). However, even at this stage, wedetected a disease modifying effect of lithium. This consisted of(i) preservation of the size of MN (SI Fig. 8 d and e); (ii)preservation of MN number and size in those areas [i.e., cervicalspinal cord (SI Fig. 9) or the nucleus ambiguous (SI Fig. 10)],which degenerate later compared with lumbar lamina IX (23,24); (iii) decreased astrocytosis (SI Fig. 11); and (iv) decreasedalpha-synuclein, ubiquitin, and SOD1 aggregation (see SI Fig. 6and Discussion in SI Text).

Effects of Lithium Treatment on the Renshaw-Like Cell Area (LaminaVII). Lamina VII contains a larger number of interneurons,defined as Renshaw cells, which form a collateral circuit that

Author contributions: F.F., P. Longone, C.I., L.M., S.R., and A.P. designed research; O.K.,M.F., M.L.M., G.L., A.S., N.B., P. Lenzi, N.M., and G.S. performed research; L.C., M.F., M.L.M.,G.L., P. Lenzi, G.S., C.I., L.M., S.R., and A.P. analyzed data; and F.F. and P. Longone wrote thepaper.

The authors declare no conflict of interest.

This article is a PNAS Direct Submission.

Freely available online through the PNAS open access option.‡To whom correspondence should be addressed. E-mail: [email protected].

This article contains supporting information online at www.pnas.org/cgi/content/full/0708022105/DC1.

© 2008 by The National Academy of Sciences of the USA

2052–2057 " PNAS " February 12, 2008 " vol. 105 " no. 6 www.pnas.org#cgi#doi#10.1073#pnas.0708022105

NATURE BIOTECHNOLOGY VOLUME 29 NUMBER 5 MAY 2011 411

A N A LY S I S

Patients with serious diseases may experiment with drugs that have not received regulatory approval. Online patient communities structured around quantitative outcome data have the potential to provide an observational environment to monitor such drug usage and its consequences. Here we describe an analysis of data reported on the website PatientsLikeMe by patients with amyotrophic lateral sclerosis (ALS) who experimented with lithium carbonate treatment. To reduce potential bias owing to lack of randomization, we developed an algorithm to match 149 treated patients to multiple controls (447 total) based on the progression of their disease course. At 12 months after treatment, we found no effect of lithium on disease progression. Although observational studies using unblinded data are not a substitute for double-blind randomized control trials, this study reached the same conclusion as subsequent randomized trials, suggesting that data reported by patients over the internet may be useful for accelerating clinical discovery and evaluating the effectiveness of drugs already in use.

Online communities such as PatientsLikeMe that provide robust methods for patients to record and share data may have the potential to be used to conduct observational studies to assess the effectiveness of treatments. Although observational studies inherently cannot meet the gold standard of randomized clinical trials, they provide an oppor-tunity to collect possibly useful early-phase data by capturing patients’ self-experimentation. Empowering observational studies of patients’ self-experimentation carries some risks. Nevertheless, an increasing level of self-experimentation is already happening1. In this context, it is possible that patient-reported outcome data collected over the Internet could be integrated into academic and/or industry-led cycles of product development and evaluation2.

Approximately half of ALS patients take vitamins and unproven supplements3, whereas a smaller number go to extraordinary lengths to experiment with unproven treatments such as stem cell transplants in the developing world4. Recently, a consortium of 75 ALS physi-cians, scientists and experts (ALSUntangled.com) has been formed

to investigate the use of self-experimentation, complementary and alternative medicine, and off-label drug usage5. There are a number of benefits to systematically studying patients’ self-experimentation. First, it is important to respect patients’ autonomy and their deci-sions; helping them participate in systematic evaluations may increase scientific literacy. Second, there is an obligation to collect data on the safety of self-experimentation. Unproven treatments might have substantial safety concerns, and risks to patients may be increased without a way to report safety issues. Finally, there is the chance that something (i.e., off-label usage, a change in dosage, delivery route or combination with other treatments) might actually be shown to be efficacious, leading to further study.

ALS is a condition where both randomized trials and nonrand-omized clinical studies have yet to provide an effective therapy. It is a cruel and rapidly fatal neurodegenerative disease causing progres-sive weakness and muscle atrophy; median survival from symptom onset is 2–5 years6. In 2008, a study described the potential efficacy of lithium carbonate to slow the progression of ALS in a small, single-blind trial of 16 treated patients and 28 controls7. Despite skepticism from the medical community8–10, some ALS patients were enthusi-astic about the treatment11 and by their own initiative used an online spreadsheet to gather data. PatientsLikeMe built a lithium-specific data collection tool (see Supplementary Fig. 1) to capture informa-tion about the 348 ALS patients registered with the PatientsLikeMe website who began taking the drug off-label via their physician. To investigate whether the major effect of lithium carbonate reported in the original study was corroborated in these 348 patients, we under-took an observational analysis of self-reported outcomes. ALS disease progression is evaluated using the Revised ALS Functional Rating Scale (ALSFRS-R12, henceforth referred to as FRS), which measures patient-reported functional impairment in domains such as speech, swallowing, walking, arm function and respiratory function. This metric is one of the standard outcome measures used in ALS clinical trials. In the absence of randomization, blinding or a placebo group, a technique was needed to overcome potential biases, such as the inherent self-selection of self-experimentation in an online sample, the placebo effect and attrition.

RESULTSParticipantsAs of the date that our data set was finalized (28 February 2010), there were 4,318 ALS patients on PatientsLikeMe, all of whom were invited

Accelerated clinical discovery using self-reported patient data collected online and a patient-matching algorithmPaul Wicks, Timothy E Vaughan, Michael P Massagli & James Heywood

Research and Development, PatientsLikeMe Inc., Cambridge, Massachusetts, USA. Correspondence should be addressed to P.W. ([email protected]).

Received 2 April 2010; accepted 10 March 2011; published online 24 April 2011; doi:10.1038/nbt.1837

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Disruptive Innovation in Health Care

WorksiteClinics

Wellness ProgramsTelehealth

/ e-Visits

Hospitalat Home

AutomatedKiosk

Services WhileTraveling Abroad

Medical Homesand Care Teams

Home Visits

RetailClinics

HomeMonitoring

WirelessHealth

Devices

Mobile CareServices

Telecommunications

PrecisionDiagnostics

Information Managementand Decision-making Tools


WorksiteClinics

Wellness ProgramsTelehealth

/ e-Visits

Hospitalat Home

AutomatedKiosk

Services WhileTraveling Abroad

Medical Homesand Care Teams

Home Visits

RetailClinics

HomeMonitoring

Wireless Health

Devices

Mobile CareServices

Telecommunications

PrecisionDiagnostics

Information Managementand Decision-making Tools

Where Do Nurses Fit In?


Care Coordination

Health Information Exchange


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Where Health Care and Digital Revolution Intersect

Health & Medicine