Eu legislation framework on e health s.stefanelli

www.studiolegalestefanelli.it

EU legis lat ion f ramework on e-Heal th

S i l v i a S t e f a n e l l i , L a w y e r


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


Data From the Electronic Health Plane 2012-2020

Some data ….

Electronic Health (E-HEALTH)


Data from the Green Paper on Mobile Health

April 2014

Some data …

Mobile Health (M-HEALTH)


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


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


•  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


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


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


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



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



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

PROFILI CLINICI


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


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


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


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


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


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


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


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


LINKEDIN MEDICAL DEVICES GROUP

Eu legislation framework on e health s.stefanelli

Health & Medicine

Transcript of Eu legislation framework on e health s.stefanelli