Digital Health Legal

Volume: 2 Issue: 4
(April 2015)


The European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) published a draft common strategy, the ‘EU Medicines Agencies Network Strategy for 2020,’ for consultation on 31 March, which includes a particular focus on strengthening regulatory transparency and making greater use of data. / read more

Turkey’s Ministry of Health (MoH) launched its new e-pulse project in April, which aims, inter alia, to enable people to manage their own health data and contribute to decisions made about their health. / read more

The Office of the National Coordinator for Health IT and the US Department of Health and Human Services, Centres for Medicare and Medicaid Services released the Stage 3 notice of proposed rulemaking for the Medicare and Medicaid Electronic Health Records (EHR) Incentive Programs and 2015 Edition Health IT Certification Criteria, on 30 March, which aims to improve the way electronic health information is shared and the way care is delivered. / read more


Ireland has underinvested in using technology to support healthcare in the past, in comparison with other EU Member States. However back in 2013 Ireland began to look at the use of health IT within the Irish healthcare system to help handle the now-familiar issues facing many countries, such as an aging population. Richard Corbridge, Chief Information Officer at the Health Service Executive of Ireland, explores how Ireland is now in the position of attempting to implement a reform of its health system that is supported by the use of eHealth from the very beginning, and in doing so how Ireland has learnt from the experiences of other countries that have sought to implement eHealth solutions. / read more

Daniel Kadar, Partner at Reed Smith, analyses the legal instability surrounding the French Sunshine Act, which has been brought into sharp focus by the recent ruling of the French Supreme Administrative Court, which on 24 February significantly expanded the scope of the law. Daniel discusses the latest developments, alongside the erratic evolution of the law, which has the potential to negatively impact the healthcare industry in France. / read more

The healthcare system in India is complex, fragmented and very unique with the predominance of the private sector, which has led to a highly inadequate record of data and poor accessibility of doctors to patients. The situation is even worse in rural areas. / read more

The United States Food and Drug Administration (‘FDA’) published draft guidance on the ‘Use of Electronic Informed Consent in Clinical Investigations’ on 9 March. Dr. Phoebe Mounts, Partner at Morgan, Lewis & Bockius LLP, provides an overview of the draft guidance and explains the benefits that broader guidance on the implementation of electronic media in clinical testing could have for the global research community. / read more

On 9 March, the Council of the EU issued a partial general approach on a key chapter (Chapter II) of the EU Data Protection Regulation, which has implications for the regulation of health data. The Council’s stance has been welcomed by a number of healthcare commentators as it promotes a more flexible approach to the use of health data and accords with the tenor of the revised version of the draft Regulation that emerged from the Council in December last year. / read more

Over the past few years, New Zealand has been putting in place an electronic prescription service, which connects community pharmacies and GPs using government controlled data and software infrastructure. The ePrescription Service (or ‘NzePS’) is now nearing full deployment, with around 11 million prescriptions processed in its first 18 months of operation. Allan Yeoman and Sarah Fitzgerald of Buddle Findlay, shed light on the rollout of the new service, and the associated privacy and security concerns. / read more

In January 2015 the German Federal Ministry of Health (‘BMG’) published the first Ministerial Draft of a bill on the ‘Law on secure digital communication and applications in the healthcare sector,’ commonly referred to as the ‘eHealth Bill.’ This draft, which the German government aims to bring into force at the beginning of 2016, is subject to scrutiny from stakeholders. A large number of politicians, associations and commentators have provided their views on the draft law, which - as Dr. Roland Wiring, Counsel at CMS Hasche Sigle, explains - seems to provide a baseline but does not appear to be the breakthrough some stakeholders had hoped for. / read more

The Minister of Social Affairs recently put forward a bill in the Icelandic Parliament on the integration of three institutions that service people with disabilites. The three institutions are the State Diagnostic and Counselling Centre, The National Institute for the Blind, Visually Impaired and Deafblind and the National Hearing and Speech Institute of Iceland. The proposed legislation is called the ‘Act on a specialized service center in the field of health and social services.’ The aim is to improve services to people with disabilities with more harmonisation and integration within a single specalised service centre, which will result in better quality and greater efficiency. / read more

About Digital Health Legal:

Digital Health Legal is the monthly publication covering legal and regulatory issues and providing industry perspectives in the health IT sector. The publication covers eHealth, mHealth apps, data protection and privacy, electronic patient records, health data security and data breaches, telehealth and telemedicine, medical devices, online pharmacies, social media, standardisation, pharmacovigilance, patient safety, Big Data, health care informatics, cloud services in healthcare, liability, IP rights and HIPAA... /read more

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