Eurohealth RESEARCH • DEBATE • POLICY • NEWS Volume 13 Number 2, 2007 Health, Technological Development and the Law Regulating nano-technology: new legal challenges? E-health: but is it legal? Zsuzsanna Jakab on developments at the European Centre for Disease Prevention and Control Dutch health insurance reform: the role of collectives • Palliative care Health service quality in Bulgaria • Experience from public-private partnerships in Eastern Europe Eurohealth Health, law and technological change LSE Health, London School of Economics and Political Science, Houghton Street, London WC2A 2AE, United Kingdom C The speed of technological advance can be truly fax: +44 (0)20 7955 6090 email: [email protected] breathtaking; possibilities that a few years ago were www.lse.ac.uk/LSEHealth confined to the realms of science fiction are rapidly Editorial Team becoming reality. Most obviously, the way in which we communicate has been transformed beyond all EDITOR: David McDaid: +44 (0)20 7955 6381 O recognition. We live in a world of instant access, email: [email protected] through mobile phones, laptops and PDAs, to the FOUNDING EDITOR: information superhighway. Moreover, social Elias Mossialos: +44 (0)20 7955 7564 networking platforms, such as Facebook, are being email: [email protected] used to a scale never envisaged by their creators; their DEPUTY EDITOR: Sherry Merkur: +44 (0)20 7955 6194 M potential for marketing and brand placement is the email: [email protected] subject of millions of euros of research. EDITORIAL BOARD: Reinhard Busse, Josep Figueras, Walter Holland, Julian Le Grand, Martin McKee, Elias Mossialos The health sector is not immune from these changes. SENIOR EDITORIAL ADVISER: Not only do we have access to health information on Paul Belcher: +44 (0)7970 098 940 the internet, albeit sometimes spurious, but we may email: [email protected] M book hospital appointments, download personal DESIGN EDITOR: medical records, use remote diagnostic technologies Sarah Moncrieff: +44 (0)20 7834 3444 email: [email protected] and perhaps purchase health care products. This SUBSCRIPTIONS MANAGER growth of e-health in all its forms, according to Celine Champa Heidbrink: +44 (0)20 7955 6840 Van Doosselaere and colleagues, has therefore as many email: [email protected] serious implications for health care regulators and Advisory Board E lawyers as it does for the medical professions. They Anders Anell; Rita Baeten; Nick Boyd; Johan Calltorp; note the uncertainty about the full legal implications Antonio Correia de Campos; Mia Defever; Nick Fahy; of using many e-health applications; further Giovanni Fattore; Armin Fidler; Unto Häkkinen; Maria Höfmarcher; David Hunter; Egon Jonsson; Meri Koivusalo; clarification, they argue, at European level is merited. Allan Krasnik; John Lavis; Kevin McCarthy; Nata Menabde; Bernard Merkel; Stipe Oreskovic; Josef Probst; Tessa Richards; Richard Saltman; Igor Sheiman; Aris N Having a more flexible legal framework to respond to Sissouras; Hans Stein; Jeffrey L Sturchio; Ken Thorpe; technological change can also be applied to the Miriam Wiley potential use of nanotechnology. As well as ethical Article Submission Guidelines concerns, resultant legal issues concerning consent, see: www.lse.ac.uk/collections/LSEHealth/documents/ privacy, and use in the context of research remain to be eurohealth.htm fully debated. In this issue Jean McHale calls for an Published by LSE Health and the European Observatory effective and pro-active, rather than reactive, EU on Health Systems and Policies, with the financial support T of Merck & Co and the European Observatory on Health response to these new challenges. Systems and Policies. Eurohealth is a quarterly publication that provides a forum Preparedness is a theme also found elsewhere in this for researchers, experts and policymakers to express their views on health policy issues and so contribute to a issue of Eurohealth. We are delighted to include a constructive debate on health policy in Europe. contribution from Zsuzsanna Jakab, Director of the The views expressed in Eurohealth are those of the authors European Centre for Disease Prevention and Control. alone and not necessarily those of LSE Health, Merck & Co or the European Observatory on Health Systems and Poli- The ECDC provides some excellent examples of how cies. technology may be harnessed to collate and The European Observatory on Health Systems and Policies disseminate information on rapidly emerging and un- is a partnership between the World Health Organization Regional Office for Europe, the Governments of Belgium, expected health threats in Europe and beyond. Finland, Greece, Norway, Slovenia, Spain and Sweden, the Veneto Region of Italy, the European Investment Bank, the Open Society Institute, the World Bank, the London School David McDaid Editor of Economics and Political Science, and the London School Sherry Merkur Deputy Editor of Hygiene & Tropical Medicine. © LSE Health 2007. No part of this publication may be copied, reproduced, stored in a retrieval system or transmitted in any form without prior permission from LSE Health . Design and Production: Westminster European email: [email protected] Printing: Optichrome Ltd ISSN 1356-1030 Contents Eurohealth Volume 13 Number 2 Health, Technology and the Law Olga Adeeva was until August 2007 Research and Development Officer at 1 eHealth…… but is it legal? the European Observatory on Health Celine Van Doosselaere, Petra Wilson, Jean Herveg and Systems and Policies, Berlin Hub, Denise Silber Germany 4 Regulating nanotechnology: new legal challenges? Lidia Georgieva is Head of Health Risk Management, MARSH Bulgaria. Jean V McHale Peter Groenewegen is Department Head, Netherlands Institute for Health Health Policy Developments Services Research and Professor of Social and Geographical Aspects of 7 Public-private partnerships in Eastern Europe: Case studies Health and Health Care at Utrecht from Lithuania, Republika Srpska and Albania University, the Netherlands. Katja Kerschbaumer Jean Herveg is Senior Researcher, Centre de Recherche Informatique et 10 Dutch health insurance reform: the new role of collectives Droit, Faculty of Law, University of Peter P Groenewegen and Judith D de Jong Namur, Belgium. Zsuzsanna Jakab is Director, European Public Health Perspectives Centre for Disease Prevention and Control (ECDC), Stockholm. 14 Medicine, care of the dying, and care of the chronically ill Milton Lewis Judith de Jong is a Researcher at the Netherlands Institute for Health Services 16 ECDC: Tackling the free movement of microbes Research and Head of the Health Care Consumer Panel. Zsuzsanna Jakab Katja Kerschbaumer is a Junior Professional Associate in the Human European Snapshots Development Department, Europe and Central Asia Region at the World Bank, 19 Promoting the quality of health services in Bulgaria Washington, D.C. Olga Avdeeva and Lidia Georgieva Milton Lewis is Honorary Senior Research Fellow, Australian Health Policy Institute, University of Sydney, Evidence-informed Decision Making Sydney, New South Wales, Australia. 21 “Mythbusters” Early detection is good for everyone Jean V McHale is Professor, Faculty of Law, University of Leicester, United 23 “Bandolier” The case for chocolate Kingdom. Denise Silber is Director and Founder, Basil Strategies. Celine Van Doosselaere is EU Affairs Monitor Manager, European Health Management Association, Brussels. 24 Publications Petra Wilson is Director Public Sector 25 Web Watch Healthcare, Cisco. 26 News from around Europe HEALTH, TECHNOLOGY AND THE LAW eHealth…… but is it legal? Celine Van Doosselaere, Petra Wilson, Jean Herveg and Denise Silber Summary: Unconstrained by familiar points of entry to health care or traditional channels for delivering information or care, the eHealth revolution has as many serious implications for health care regulators and lawyers as for medical professionals. In the context of the Commission’s eEurope Action Plan, the “Legally eHealth” study established a baseline report on existing EU level legislation, its impact on the delivery of eHealth and an analysis of the legal and regulatory barriers and gaps that may exist. This article gives an overview of some of the issues studied and key recommendations made. Keywords: eHealth, Security and Privacy, Liability; Data Protection and Ownership eHealth is a broad term with many defini- In response to the lack of legal certainty such as picture archiving and communica- tions, including health informatics, health about the use of eHealth tools, the tions systems (PACS), as well as clinical telematics, ICT (information and commu- European Commission, through its support systems such as operating theatre nication technology) for health, connected eHealth Action Plan, called for a study to systems (OR), decision support systems health, medical computing, or medical establish a base-line report on existing EU (DSS); and systems linking key health care informatics, all of which are used to level legislation, its impact on the delivery actors such as General Practitioners describe the use of a wide range of infor- of eHealth and an analysis of the legal gaps Systems, and electronic prescribing mation technology applications and which may exist. The ‘Legally eHealth’ systems linking general practitioners (GPs) services in the healthcare setting. For the study, which we present in this article, was with pharmacies (eRx). ‘Legally eHealth’∗ study described in this completed in