e-Healtha UEMS perspective

14th annual "National Medical Specialty Training Conference"Turkish Medical Association, Ankara, 29 Nov 2008

Peter M. Pattynama, MD, PhD

Professor of interventional radiologyErasmus university Medical CenterRotterdam (NL)

President, UEMS radiology sectionRapporteur, UEMS working group on e-health

p.m.t.pattynama@erasmusmc.nl

e-Health

• e-Medicine

Electronic Patient Record

Professional-to-Professional telemedicine (teleradiology, -pathology)

Professional-to-Patient telemedicine (telemonitoring)

• e-learning

Postgraduate Medical Specialist Training (residents)

CME/CPD programs (medical specialists)

Where do we stand today?

• e-Medicine

Much activity

New European Commission initiatives to promote e-Medicine

Market developments

UEMS position in response

• e-learning

Efforts mainly by medical specialty organisations

UEMS accreditation for e-learning

e-Medicine: European ContextIncreased demand for healthcare, higher cost• Ageing population• Growing prevalence of chronic disease• Better quality, more therapeutic options

Decrease of active workforce

Spirit of EU• Free movement of persons, goods, services and capital

Economic incentives• Market potential of e-Medicine for EU• Creating economic growth and jobs to EU citizens

Similar but Different !Patient mobility: Cross-border healthcare• Driving principle: consumer choice• Patient’s own choice to go abroad• Free movement within EU• Provider: National healthcare system of another EU country

e-Medicine: Cross-border healthcare• Driving principle: Free market, Global competition, comparative

advantage, cost control, capacity issues • Not the patient’s choice, patient stays within his own EU country• Provider: for-profit commercial player with global reach• May be located in (low wage-) countries outside EU

Hoped for prospects: e-HealthSpirit of EU• eHealth, as ICT solutions for patients, medical services and payment

institutions can help deliver better care for less money;• “ eHealth, one of the priorities of the EU's i2010 programme to boost

innovation and jobs …”• eHealth, One of the first six lead markets: markets in which EU industry

can develop a global competitive advantage ..”

Market potential for eHealth estimated as 1/3d of world market or 20 billion euro per year.

cf: EU pharmaceutical market 205 billion

EU medical technology 64

UEMS positionUEMS’s Bratislava declaration 2007

1. e-Medicine is becoming everyday’s practice in EU

2. e-Medicine has the potential to significantly improve quality of care. Quality must have priority over increased cost-efficiencies.

3. Electronic patient records are inevitable, and will contribute to higher standards in medical specialisation and healthcare.

4. However, UEMS is concerned about recognized risks to security of data, confidentiality, medical ethics and the law.

Therefore, UEMS commits itself to promote and control

- respect for security and privacy of persons

- respect for medical ethical principles

- validity of electronically stored health information

- quality of electronic medical education and training

UEMS responseCreation of a working group on e-health, October 2008

Aim:

To review and to discuss e-Health issues

To formulate views on e-Health matters as they relate to professional practice and to patient-related issues for specialist doctors in the European Union.

The WG will prepare policy papers for approval by the UEMS Council, as statements of the UEMS point of view.

European Commission documents• Proposal for directive on cross-border healthcare, July 2, 2008• Recommendation on e-Health records, July 2, 2008• Communication on Telemedicine, Nov 4, 2008

EU documents and law (1)EU rules• are automatically part of national law of all EU member states• Aim is to arrive at one common judicial system

EU directives (recommendations)• Guidelines that should, in one way or the other, be incorporated in

national law• Aim is to make national law systems more similar

EU communications• Soft power to influence EU member states• The European Commission takes a position

EU law (2)Health care follows “principle of subsidiarity” (i.e., should be handled

by the lowest authority possible) (1992 treaty of Maastricht)

Management of national health care systems are decided by each

of the EU member states for themselves

But the European Court of Justice ruled that:

“EU treaties apply also to health care”

EU directives and recommendations (!) supersede national law even if this has implications for national health care

EU law (3)EU directives with direct implications for national health care

• Can apply to environmental health issues to protect citizensDirective 96/29/EC Euratom (radiation exposure in medicine)

• Or to social issues to protect workers

Directive 2004/40/EC EMF - electromagnetic fields directive (MRI?)

• Or to internal market & consumer protection

Directive 2000/31/EC “e-Commerce directive” (telemedicine)

EU law (4)• EU laws are prepared by 37 Directorate Generals

(Compare: ministries)

• Under authority of a EU Commissioner (compare, minister)

• Large organizations of civil servants

• Headed by Director-General (civil servant)

Directive 97/43/ Euratom

Directive 2004/40/EC - EMF

DG Health and Consumer Protection• SANté & protection des Consomateurs = SANCO

Euro Commissioner: Androulla Vassilliou (Cyprus)

• Management of national health care systems are decided by each

of the EU member states for themselves

• Programs for• Consumer protection• Public health• Food safety

European Parliament

Europarliament resolution, 23 May 2007:• Cross border issues are a matter for the EU• EU members states insufficiently promote health care

which restricts patients’ rights• Cross border health care will grow and will increase quality and accessibility• Patient and professional mobility ensures free movement of citizens• Wants member states to actively support e-health and telemedicine• Legal and reimbursement issues need to be solved

European CommissionConsultation of the public on patient mobility 2006-2007

Most respondents favored community action on health services:

• Growing scale of cross border health care• Need for greater clarity about judicial limits• Expect EU support to improve quality and safety of health care• Support national health systems by establishing EU networks,

centers of reference to share information and innovations

European Commission indicated that patients safety and mobility

will be a key political priority for 2008

Where are the doctors …?To the European Commission and the DGs there are only a few relevant

groups representing doctors in the EU to consult with:

• CPME – Comité permanente/Standing committee of European doctors

• UEMO – European Union of General Practitioners

• UEMS – Union Européenne des médecins spécialistes

European union of medical specialists

For practical reasons, the scientific organisations representing the >39 medical specialties, are not consulted on a routine basis

This is why we should use UEMS as a vehicle to get our message across

Directive on Cross-border Healthcare• proposal, July 2, 2008, COM(2008)414• to be discussed in Europarliament December 2008• Prepared by DG SANCO• Directive on the application of patients’ rights in cross-border healthcare

• goal: clarify entitlements for EU citizens to receive non-emergency health care in other EU member states (without prior authorization)

• enhance patient mobility across internal EU borders

• contains art. 16 on “E-Health”:• will achieve measures necessary for interoperability of information and

communication technology systems in the healthcare field• to ensure safe, high-quality and efficient data transferral across borders• focus on technology issues and protection of personal data

Communication on Telemedicine• Nov 4, 2008, COM(2008)689• Prepared by DG Information Society and Media (Commissioner Reding)• Communication on telemedicine for the benefit of patients, healthcare

systems and society

• goal: increase and broaden telemedicine services, i.e., delivery of healthcare including diagnosis, treatment and monitoring at a distance across Europe.

• Professional-to-Professional vs Professional-to-Patient telemedicine

• Calls for specific action of member states• building trust and acceptance of telemedicine• facilitating market development• bringing legal clarity• Telemedicine currently explicitly NOT a medical act in many member

states

Recommendation on eHealth records• July 2, 2008, COM(2008)3282• Prepared by DG Information Society & Media (Commissioner Reding)• Recommendation on cross-border interoperability of electronic health

record systems

• goal: improve sharing of medical data across institutions and across borders within EU

• contains basic principles and guidelines for ensuring that doctors can access vital information about their patients, wherever such information may be located in Europe

UEMS and ESR position• Teleradiology (telemedicine!) is a reality• In essence, is positive: improves quality and accessibility to radiology services• Technical issues not limiting, neither patient acceptance, nor quality of service• Practice of telemedicine should be well regulated

to ensure quality of care & patient safety

(and we have seen bad examples of unregulated teleradiology …)

Issues in TelemedicineA Risks regarding responsibility & accountability

Teleradiology providers: commercial for-profit firms inside/ outside of the EU

B Legal/medical risks:

Telemedicine not a medical act?

interpreting without clinical context

C Uncertain how teleradiology will be implemented

involvement of local radiologists?

Bad UK-example: No involvement of local radiologists

NHS hires teleradiology capacity

Good EU examples: local radiologists are primarily involved

Isolation from clinical context• Teleradiology services are remote• Have limited access to patient files, current and historic lab data, imaging studies• No face-to-face conferencing with treating doctors

Medical-ethical concern

The interpretation of an imaging study will change according to this additional information (the clinical context)

This will result in overcautious, or vague reporting: “defensive medicine”

Calling for extra unnecessary/inappropriate tests, driving up costs and waiting lists

Legal concern

Many EU countries require by law that all available information should be used

when interpreting radiology examinations, to ensure optimal quality of care

Dans E, et al. Tijdsch Gezondheidsrecht [J Health Law] 2008,32: 187

Clinical context (1)

• Metastasis of cancer !

Clinical context (1)

• Lab:

Alk. Phosph. = 216 IU / l

• Metabolic disease (Paget) !

Clinical context (2)

• Lung cancer !

Clinical context (2)

• CT of 5 years prior: Unchanged

• Irrelevant, benign nodule !

UEMS (and ESR) positionA Risks regarding responsibility & accountability

B Legal/medical risks

Telemedicine should be classified as a medical act

Doctors offering telemedicine services should be held to the same professional and medical-ethical standards as doctors who offer standard (non-telemedicine) healthcare services

Regulation of telemedicine is the responsibility of the EU member state where the patient seeks treatment

Directive on Cross-border Healthcare• proposal, July 2, 2008, COM(2008)414• to be discussed in Europarliament December 2008• Prepared by DG SANCO• Directive on the application of patients’ rights in cross-border healthcare

• goal: clarify entitlements for EU citizens to receive non-emergency health care in other EU member states (without prior authorization)

• enhance patient mobility across internal EU borders

• contains art. 16 on “E-Health”:• will achieve measures necessary for interoperability of information and

communication technology systems in the healthcare field• to ensure safe, high-quality and efficient data transferral across borders• focus on technology issues and protection of personal data

UEMS positionThe directive should not only address IT-aspects of telemedicine but also

general principles of quality and safety of patient care:

To art. 16 about e-Health should be added:

Specific telemedicine services should be classified as medical acts.

The use of telemedicine should adhere to the same professional medicalquality and safety standards as conventional health care

Communication on Telemedicine• Nov 4, 2008, COM(2008)689• Prepared by DG Information Society and Media (Commissioner Reding)• Communication on telemedicine for the benefit of patients, healthcare

systems and society

• goal: increase and broaden telemedicine services, i.e., delivery of healthcare including diagnosis, treatment and monitoring at a distance across Europe.

• Professional-to-Professional vs Professional-to-Patient telemedicine

• Calls for specific action of member states• building trust and acceptance of telemedicine• facilitating market development• bringing legal clarity• Telemedicine currently explicitly NOT a medical act in many member

states

UEMS positionUEMS welcomes many of the principles put forward in the communication on

telemedicine. In fact, these should be incorporated in the Directive on Cross-border healthcare

“Specific telemedicine services should be classified as medical acts.This principle ensures that adequately regulated health services are not replaced

by less regulated telemedicine services.”

We welcome the call for actions regardingDevelopment of reimbursement schemes for telemedicine Training for health professionalsBringing legal clarity

Recommendation on eHealth records• July 2, 2008, COM(2008)3282• Prepared by DG Information Society & Media (Commissioner Reding)• Recommendation on cross-border interoperability of electronic health

record systems

• goal: improve sharing of medical data across institutions and across borders within EU

• contains basic principles and guidelines for ensuring that doctors can access vital information about their patients, wherever such information may be located in Europe

UEMS positionUEMS welcomes the recommendation but thinks several issues need to be further addressed:

•What characteristics should an international e-Health system have to be a useful tool for patients and professionals?

•What level of security is desirable and should physicians’ organizations participate in monitoring the safety of the system?

•What level of centralization of data storage is desirable (the level of individual hospitals, regional or national, or supranational)?

•Should summary or detailed patient records be available?

•How should access privileges be governed? Should there be registries where all users will be certified?

•How much privacy should the system assure? Should there be an emergency access to patient records that will not require patient’s authorization?

•What terminology and classifications should be used in interoperable medical records?

E-Health

• e-Medicine

Much activity

European Commission initiatives to promote e-Medicine

Market developments

UEMS perspective

• e-learning

Efforts mainly by medical specialty organisations

UEMS accreditation for e-learning

e-Learning in radiology

• European radiology has recognized huge potential of e-learning• Radiology is especially well-suited for e-learning (for the same

reasons that teleradiology is so successful!)• European Society of Radiology has initiated e-learning projects:

ESR electronic congress

ESOR Virtual School

ESR electronic congress• Since 2003, the annual ECR meeting uses an all-electronic format for

scientific exhibitions

• All congress abstracts are available in electronic format

• All slide presentations are electronically kept

• The various subspecialty societies have followed suit, CIRSE, ESGAR, ESMRMB, ESCR, ESSR, (plus the American SIR)

The ESR electronic congress comprises:• over 11,750 abstracts• over 1,060 PowerPoint™ presentations to download• over 280 recorded lectures / webcasts• over 3,740 electronic exhibits

accessible for ESR-members via one single platform.

ESOR Virtual School• The ESR organizes so-called GALEN-foundation courses in the context of its

European School of Radiology

• Aim: to harmonize radiology training in Europe

• Aimed at radiology residents in years-1, 2, and 3

• Taught by eminent European faculty

• Abdominal, cardiovascular, chest, neuro-, muskuloskeletal radiology and oncological imaging

• These courses have been made available in electronic format in the “virtual school”

accessible for ESR-members via one single platform

e-Learning in radiology• There is ample study material for e-learning available on-line

• Yet, a true beneficial effect is unknown

• (Turns out to be less popular than initially anticipated?)

Potential reasons

• e-learning material only recently available

• not clear how e-learning can be incorporated in regular training:

not yet award-system for e-learning in radiology training (but this could be the responsibility of national radiology societies!)

• until recently, no award-system for e-learning for CME/CPD

Our professional responsibility• Promotion of e-learning is our responsibility• The European Commission has relatively lack of in-depth expertise

of medical field & problems• Trust in doctors to provide directions, guidelines• View that such appropriate guidelines will become incorporated in

law

• It is critical that we, as professionals, develop and publish our view

on the use of e-learning in postgraduate medical specialist training• Developed by specialists• Endorsed by mother specialty (ESR)• Brought into the political discussion through UEMS

UEMS positionAccreditation of e-learning materials by EACCMEAdopted in Copenhagen, 11 October, 2008

European Accreditation Council for Continuous Medical Education:

Other, non-traditional means of CME/CPD are acceptable to obtain credits, including audio recordings, video recordings, and on-line websites.

These materials and the providers have to comply with the EACCME quality standards

The credits are valid in those member states that have a recognition agreement with the EACCME

Where do we stand today?

• e-Medicine

Much activity

New European Commission initiatives to promote e-Medicine

Market developments

UEMS position in response

• e-Learning

Efforts mainly by medical specialty organisations

EACCME accreditation for e-learning

E-learning responsibility of the medical field

Prof. Peter Pattynama (NL)President, UEMS radiology section

p.m.t.pattynama@erasmusmc.nl