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Regulation Is a Crucial yet Misunderstood Componentof Effective Digital Health Strategy in the EU
e-Health solut ions Impact stud i es Consult ing Analyt ics IMPROVE patients’ LIVES
E-HEALTH INNOVATION:NAVIGATING THE EU REGULATION JUNGLE
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Digital innovation: creating value for all stakeholders
Regulatory pitfalls
Innovative ehealth solutions have the potential to improve health outcomes and create value for all healthcare industry stakeholders. Pharmaceutical companies play an important role in driving innovation and increasingly provide digital services to patients and payers.
The European market is attractive for launching innovative digital health solutions given the market maturity, generous reimbursement policies and prevalence of chronic conditions. However, EU regional marketing and digital leads face significant challenges in implementing innovative digital health solutions given the region’s regulatory complexity.
The example demonstrates the need for regional marketing and digital leads to have a concrete, detailed understanding of market requirements in each EU country in order to avoid wasted budget, development / launch delays and / or missed performance targets.
In-house local legal experts are one of the resources available to manage these issues, and can provide valuable input regarding the scope of what is acceptable in their market prior to solution development and launch. However,
A recent example is the development of electronic Patient Reported Outcomes (ePRO) tools to support patients such as cancer patients with their treatment. These solutions offer patients
better tracking and management of their condition, while physicians and healthcare providers can optimize precious consultation time and care. Furthermore, the potential of such programs to generate valuable real-world data, for example on treatment efficacy, is appealing to payers, as it allows for both more efficient and personalized resource allocation and an improved understanding of treatment efforts at the population level (value-based healthcare).
However, pharmaceutical players may face challenges when implementing such innovative solutions in European markets (EU) given the complexity of the regulatory environment.
Consider the illustrative example we could envision for an Observia client.
1 million€An EU marketing team spends ca. 1M€ to develop an
application for Type II diabetes patients
Only to discover that the app needs further technical modifications due to specific requirements in the pilot
country (at a cost of 200 000€!) to be deployed.
EXAMPLE
In-house legal experts are not always available and / or do not have immediate availability. Waiting for their input may delay innovative program implementation.
In-house legal teams may be risk-averse, further hindering the development of innovative programs.
200 000€
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Observia’s eHealth Compliance Framework for Europe
Program promotion & branding
The promotion of innovative digital health solutions has important implications. Direct to consumer advertising for healthcare products is generally prohibited in the EU. Innovative digital health projects intended as services to HCPs are subject to regulations governing branding, communications and bribery, among others, with significant implications for program design. In the EU, each member state defines laws governing promotional topics like branding and provision of services to HCPs. Chart 2 demonstrates that there
is a high degree of variability in terms of what is permissible regarding promotion between the different European countries.Regional leads in charge of digital healthcare innovation programs should be aware of the differences between countries when designing promotion and branding strategies to ensure that they are appropriate for the country and solution (See Chart 2 for detail).
While the EU sets a minimum regulatory framework for digital healthcare solutions that every member state must respect, individual countries may impose additional rules. Chart 1 gives more detail on types of regulation that might apply for each of the regulatory topics.
When launching a digital healthcare innovation, it is necessary to consider 3 main business and technical axes with legal implications:
Chart 1: Innovative Digital Health Solutions: Legal & Compliance Areas
Local RegulationEU Regulation
Commercial solutions offered by pharmaceutical companies are subject to local regulation regarding promotion, including branding.
Healthcare related software solutions may qualify as medical devices according to EU regulation (Medical Device Regulation 2017/745).
Promotion and branding of the solution
Data Collection, specifically issues raised by the collection of patient dataEU (GDPR) + Country Regulation
The collection of patient & treatment-related data is subject to EU (General Data Protection Regulation) & local regulation.
Purpose + Functions & Legal Status of the innovative digital health solution
01 02 03
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Chart 2: When is Promotion Legal: Summary by Branding & Communication Channels
Examples of Italy, Belgium, Germany and SpainAllowed:
Allowed understrict conditions:
Not allowed: Allowed underconditions:
Unassociated unbranded
Italy
Patient education tools supporting onboarding and adherence to new medications
Direct-to-Consumer advertising campaigns
Omni-channel campaigns
External affairs specific activities
PSPsSpecificities between branded and unbranded
Disease & Device education: Patient self-injection video, Self-injection guide, Device training kit, Patient FAQ
In-office tools and sales-force messaging about the campaign
Communication & PR activities
TV advertising
National and regional events
Office tools: Patient-HCP dialogue tools, leaflets, brochures, posters
Direct-to-patient digital and TV activities
Partnership activities with PAGs
Digital advertising: website, social media, Branded CRM
Medical congresses
eLearning tools: Patient website
Specific events at global or country level
Public Health initiatives
Communication & PR activities
Branded
Branded
Branded
Branded
Branded
Branded
Branded
Branded
Branded
Branded
Branded
Branded
Branded
Branded
Branded
Associated unbranded
Associated unbranded
Associated unbranded
Associated unbranded
Associated unbranded
Associated unbranded
Associated unbranded
Associated unbranded
Associated unbranded
Associated unbranded
Associated unbranded
Associated unbranded
Associated unbranded
Associated unbranded
Associated unbranded
Unassociated unbranded
Unassociated unbranded
Unassociated unbranded
Unassociated unbranded
Unassociated unbranded
Unassociated unbranded
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Unassociated unbranded
Belgium Germany Spain
As of June 2016
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At Observia, we recommend that regional leads consider the following questions regarding promotion and branding: before launching a digital health solution
When is the branding of the digital health innovation legally acceptable? What are the implications for communications?
What are the implications for solutions that “push” information to patients?
Should the solution only be offered to patients on a certain treatment?
What are the implications of providing such solutions to HCPs free of charge?
Observia recommends considering the following questions regarding data collection: before launching a digital innovation product.
What are the requirements for data collection as imposed by GDPR? Are there additional country-specific requirements that apply?
Is there interest in using the data collected for additional analyses? What are the implications in terms of pharmacovigilance reporting, observational study requirements, etc.?
Data collection Data collection is a fundamental component of innovative digital health solutions, enabling better tracking of patient symptoms and experience for optimized care. The EU General Data Protection Regulation (GDPR) imposes specific requirements for the collection of personal data in general and contains specific requirements for health data collection.While the data protection requirements imposed by
GDPR constitute the legal basis for all countries in the EU, some countries impose additional requirements for health data collection that are less well known. For example, France requires that companies hosting patient data obtain additional certification, e.g. the Hébergeurs de Données de Santé or Health Data Hosting (HDS) certification.
Observia recommends considering the following medical device status-considerations prior to launching a digital innovation product.
Could a digital innovative solution be considered a medical device given its purpose and functionalities? Is so, what are the implications for launch in terms of budget and timing?
Purpose, functionalities and legal statusDigital health solutions intended for diagnostic purposes or having functionalities implicated in diagnostic decisions may qualify as medical devices and require certification to be legally marketed in the EU. Digital Health solution purpose and function
should be carefully considered during the design phase to determine whether medical device status and certification – a time-consuming, expensive process – is appropriate.
Given the various legal requirements that could apply, regional leads need to be purposeful from the innovation design phase to minimize regulatory burden.
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How to Get Started Developing Innovative Programs
At Observia, we appreciate the complexity of developing innovative digital health solutions, and the collaboration that is needed for success. Based on our experience, we recommend taking the following steps from program launch to ensure program compliance:
Leverage your internal expertise by bringing together stakeholders:
Define Program KPIs
Legal and compliance, medical, IS, Data Privacy, Safety leads should all be engaged in the project.
At Observia, we are experts in the development of digital innovations in Europe and worldwide. We can help you navigate the complexity of European regulation and achieve your goals.
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03 Adhere to internal Standard Operating Procedures (SOPs)
Local teams will need to keep in mind company-specific SOPs applicable to innovative digital programs.
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Define and align on project purpose
Defining program purpose has important implications when data collection is involved.
Example of purpose: understanding which patients get the most value from the implemented digital health solution.
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Data collection metrics have implications for the definition of commercial activities versus studies.
Example of KPI: patient satisfaction and demographics.
We are Here to Help
We are here to collaborate and find the right answers to the right questions at the right time. Contact us with your questions
to find out how we can help!
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About ObserviaOUR MANTRA
Improving patients’ lives and easing healthcare professionals’ daily life is our mantra.
Observia accomplishes this by creating uniquely personalized, high impact, industry-leading beyond-the-pill solutions that win the hearts and minds of all involved, including patients,
caregivers, healthcare professionals and payers.
To help our clients achieve their diverse goals, including Life Science companies, government & private insurers, hospitals, patient associations and others, we provide a rich array of services & technology-driven solutions along the ‘journey of patient engagement’:
Improving patients’ lives and easing healthcare professionals’ daily life is our mantra.
eHealth solutions
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Consulting
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Real world impact studies
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Understanding patient behaviour.
Understanding of usage and preferences of
different stakeholders
Behavioural science Healthcare eco-system E-health technology
Know-how and skill tointegrate technology andtools into one coherent
service offering.
Our know-how is the combination of three strong expertises.
OUR KNOW-HOW
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WHAT MAKES US UNIQUE
Observia combines expertise in behavioral science, technological know-how and knowledge of healthcare eco-systems. In particular, we have developed SPURTM a proprietary innovation.
SPURTM is a unique universal digital model that allows to identify the behavioral drivers of chronic patients and assesses their risk of non-adherence and level of support needed. The model has been under development for the last three years, with support from international behavioral sciences experts, and additional studies are being conducted in 2019.
SPURTM revolutionizes the way we offer support to chronic patients and can be integrated into any existing program (thanks to digital interoperability). We are convinced it will disrupt the way services are provided to patients by providing personalized, efficient and qualitative support that fits patients’ preferences and attitudes.
SOME OF OUR PROJECTS
Canada
Guadeloupe
Brazil
India
Indonesia
China
Europe
United Arab Emirates
United States
PSP Design digital tool
Mobile app to improve AOD adherence - Prix Galien 2017
Local PSP assessment
Type 2 diabetes personalized
Peritoneal dialysisAdherence benchmark
local PSP
Algeria
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