The document discusses the EU legislative framework for e-health and m-health. It summarizes key EU actions and documents that aim to develop interoperability of e-health systems across borders, ensure patient identification and data protection, and support increased use of telemedicine and mobile health technologies. Issues around legal classification of m-health apps and ensuring security of big data are also addressed.

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EU legislation framework on e-Health
Silvia S tefanelli, Lawyer

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… Let’s start from the data …
… and then move on to the regulatory framework …

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Data From the Electronic
Health Plane
2012-2020
Some data ….
Electronic Health (E-HEALTH)

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Data from the Green
Paper on Mobile Health
April 2014
Some data …
Mobile Health (M-HEALTH)

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Article 168
Treaty on the Functioning of the European Union (2007)
(ex article152 of thel TCE)
1. A high level of human health protection shall be ensured in the definiton and implementation of
all Union policies and activities.
4. The Unione shal encourage cooperation between the Member States in the areas referred to in
this Article and, if necessary, lend support to theri action.
It shall in particular encourage cooperation between the Member States to improve the
complementarity of their health services in cross-border areas.
.
Legal Profiles

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COM (2004) 356 of the 30 April 2004
eHealth – Making HealthCare Better for Eureopean Citizens
Action Plan for a European eHealth Space
• Increasing age of the population (40% in 2052 will have + 65 years)
• More user expectations
• Increasing mobility of patients
• Reduce the disease burden and the epidemiological risks
• Difficulties of the Public Administration to harmonize investment in technology
• Reducing accidents and occupational diseases
• Data management in healthcare
• Providing health care facilities with limited equipments
The challanges of national health systems in Europe

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• Developing the leadership role of each Member State
• Developing the interoperability of eHealth systems
• Patient identification (interoperability of medical records)
• Patient mobility
• Improving infrastructure and technologies
• Accreditation for an eHealth market
• Stimulating investments
• Harmonizing the legal and regulatory profiles
COM(2012) 736
eHealth Action Plan 2012-2020 – An Innovative HealthCare
COM (2004) 356 of the 30 April 2004
eHealth – Making HealthCare Better for Eureopean Citizens
Action Plan for a European eHealth Space

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Clinical Profiles
Patient
Organizational
Profiles
interoperability of systems
patient identification
data Management
mobility
connection with the
system (mHeath)
telemonitoring - telemedicine
confidence in the patient
legal framework

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Develop the Interoperability of Systems
Towards the Interoperability of European Public Services
ê
COM (2012) 736
By 2015, the Commission set itself the goal of:
• determine the specifications and the semantic and technical resources for cross-border interoperability
necessary for the framework for the interoperability of eHealth;
• propose interoperability testing, labeling and quality assurance framework for eHealth systems at EU
level;
In the framework of the epSOS project were defined the possible ways in which the Member States can
cooperate and integrate their processes in order to diffuse the e-Health services across Europe
ORGANIZATIONAL
PROFILES

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Patient Identification (Interoperability of Medical Records)
Commission Reccomendation about cross-border electronic medical records
(2008/594/EC)
The interoperability of electronic health records involves the transfer of personal
data about the health of a patient:
they should be able to move freely between every Member States by protecting
at the same time the fundamental rights of the individual.
COMMITMENTS OF MEMBER STATES
ORGANIZATIONAL
PROFILES

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Patient Identification (Interoperability of Medical Records)
Commission Reccomendation about cross-border electronic medical records
(2008/594/EC)
Cross-border interoperability
Technical interoperability
Semantic interoperability
Certifications of the systems of electronic health records
Protection of personal data
Monitoring and evaluation
ORGANIZATIONAL
PROFILES

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COM(2008)689 final on Telemedicine for the Benefit of Patients, HealthCare
Systems and Society
Two clinical instruments analyzed
Telemonitoring - Teleradiology
THE CHALLANGES
Create confidence in patients (evidence on the effectiveness)
Legal clarity (data and liability, refund, jurisdiction)
Dir 2000/31/EC Electronic Commerce (rules of the Country of origin)
Dir 95/46/EC Personal Data Protection
Dir 2002/58/EC Personal Data Protection in the Electronic Communications
Dir 2005/36/EC Requirements for the Recognition of Professional Qualifications
PROFILI CLINICI

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Patients Mobility
DIR 2011/24/EU
on the Application of Patient’s Rights in Cross-Border HealthCare
Art. 14
The Union shall support and facilitate cooperation and exchange of information
among Member States working within a voluntary network connecting national
authorities responsible for eHealth designated by the Member States.
PATIENTS

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GOALS OF ONLINE HEALTHCARE NETWORK:
• Take advantage of the benefits of sustainable economic and social systems and European services of
health care online and of the interoperable applications in order to achieve a high level of trust and
security enhancing continuity of care and ensuring access to safe and high quality healthcare;
• Elaborate guidelines concerning:
- a non-exhaustive list of data to be included in patients' summaries and that can be shared between
health professionals to enable continuity of care and patient safety across borders;
- effective methods for enabling the use of medical information for public health and research;
• Support Member States in developing common identification and authentication measures to facilitate
transferability of data in cross-border healthcare.
PATIENTS

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What is the mHealth?
WHO - "mHealth – New horizons for health through mobile technologies, Global Observatory for eHealth
series – Volume 3”,
“Practice of medicine and public health supported by mobile devices such as mobile phones
patient monitoring devices, handheld computers (PDAs) and other wireless devices"
Apps for wellness and lifestyle that can connect to medical devices or sensors (bracelets or watches)
Systems of personal advice
SMS with health information and
Reminders of medication taken
telemedicine through wireless communications
PATIENTS

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POTENTIAL OF THE mHEALTH
Health Care
• Priority to prevention and quality of life
• Self – assessment and diagnosis at a distance, overcoming of the resistance, motivation
and involvment
• More efficient and sustainable Health Care
• Better planning,
• Reduction of unnecessary consultations
• Better preparation of professionals, who will have information about therapeutic
treatments
• Save up to 30% of the time required to access information and analyze tem (PWC,
Socio-economic impact of mHealth – 2013 Jun )
• Strengthening of the active role of the patient
• From a rather passive subject it becomes more involved and more responsible of
his own health
• Self-motivation and compliance with the prescriptions
• Professionals’ evolving role

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POTENTIAL OF THE mHEALTH
Market
mHealth Market
OMS "mHealth – New horizons for health through mobile technologies,
Global Observatory for eHealth series – Volume 3”
• Other income Countries – to cut costs
• Developing Countries– to access to basic health care
• Importance of Personal Health Systems
APP Market
Research2Guidance(2013) "The mobile health global market report
2013-2017: the commercialisation of mHealth apps"
• By 2017 3,4 billion of people will own a smartphone, the half of which will use the App of
mHealth
• 97.000 mHealth App are currently available on the global market
• About 70% of the market of wellness and fitness;
• About 30% is intended for health professionals and facilitates the access to patient
data, consultation and patient monitoring, diagnostic imaging, access to information
on pharmaceutical products

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ISSUES TO DEAL WITH
Protection and Data Security
• Only 23% of consumers have already used mHealth applications
• 67% said that they did not want to “do anything” for their health with mobile
• 77% never used the phone for activities related to health
Boehm. E, Mobile Healthcare's Slow Adoption Curve, 2011, Forrester Research, Inc.
Dangers
Distribution to Third Parties (insurance, pharmaceutical companies, etc. )
Difficulty of transfer from one platform to another

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ISSUES TO DEAL WITH
BIG DATA
Ability to analyze a variety of data sets (unstructured) from a wide range of sources
Within the next decade the data coming from personal sensors will pass from 10% to about 90% of all
information stored.
Improving Public Health and Medicine by use of Reality Mining, Pentland. A, et al 2009, Robert
Wood Johnson Foundation.
USE OF BIG DATA
• Epidemiological research (relation between pathology development and environmental factors)
• Help in reducing medicines trial periods
• Develop more advanced mechanism for early detection
• Diseases prevention and elaboration of innovative business models in this area
• Increase productivity and cut costs
PROBLEM: EFFICIENT BUT SAFE USE

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ISSUES TO DEAL WITH
LEGAL CLASSIFICATION
The APPs are Softwares
When do they have to be qualified as a medical device?
• MED DEV MEDDEV 2.1/6 GUIDELINES ON THE QUALIFICATION AND CLASSIFICATION OF STAND
ALONE SOFTWARE USED IN HEALTHCARE WITHIN THE REGULATORY FRAMEWORK OF MEDICAL
DEVICE
• MED DEV BORDERLINE, 2014 July
• MHRA Guidance on medical device stand-alone software (including APPs)
• MEDICAL INFORMATION SYSTEMS (Svezia 2013) – Guidance for qualification and classification of
Medical Information Systems
• FDA Guideline of the american FDA called Mobil Medical Application - Guidance for Industry and Food and
Drug Administration Staff, September 25, 2013
• IMDRF – Software as medical device: Possible Framework for Risk Categorization and Corresponding
Consideration 2014 Sept

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LINKEDIN
MEDICAL DEVICES GROUP