Digital Health Legal

Volume: 2 Issue: 11
(November 2015)


The UK’s Information Commissioner’s Office (‘ICO’) has fined online pharmacy Pharmacy2U Ltd Ł130,000 for selling the names and addresses of 21,500 patients without their consent, in what is described in the ICO’s monetary penalty notice published on 20 October as ‘a serious contravention’ of UK data protection legislation. / read more

The European Parliament’s adoption on 27 October of a regulation on net neutrality, which also ends EU-wide roaming charges, will impact eHealth operators. The rules allow for ‘specialised services,’ permitting optimised internet access services at higher prices as long as the services require both higher quality and reliability and could not be provided otherwise. The regulation specifies telemedicine as among these ‘specialised services.’ / read more

The Center for Devices and Radiological Health (‘CDRH’), part of the US Food and Drug Administration, published on 20 October its ‘Regulatory Science Priorities for FY 2016,’ which highlights ten areas to be prioritised in order to improve the safety of medical devices and innovation; a number of these areas involve eHealth. / read more


Should medical doctors, clinical trial researchers, or information scientists in biotech or health information management lose any sleep over a case brought against Facebook? Griet Verhenneman, of the KU Leuven Centre for IT & IP Law, believes they should. What started as a request by Austrian Maximillian Schrems to investigate data transfers from Facebook Ireland Ltd. to Facebook Inc., turned into a landmark judgment by the European Court of Justice (‘CJEU’) on international data transfers, with far-reaching consequences. The CJEU has declared the US Adequacy Decision, generally cited as the Safe Harbor Decision (‘Decision’), null and void. Consequently some 4,000 US companies, who transfer data between the EU and the US based on the Decision need to review their data transfers, as Griet explains. / read more

Amid protests by brick-and-mortar pharmacies concerned about the rise of online pharmacies in India and action by state drug control departments against e-commerce companies allegedly involved in the distribution of medicines via the internet, Indian regulatory body the Drug Consultative Committee is currently working on a regulatory framework for online pharmacies in the country. Dr Milind Antani and Anay Shukla of Nishith Desai Associates outline the background to the controversy involving Indian online pharmacies and explain the legal issues such businesses currently present. / read more

The primary aim of the UK’s Health and Social Care (Safety and Quality) Act 2015 was to remove the risk of a repeat of the tragic events at Stafford Hospital, and to encourage integration in health and social care in England. The Bill was drafted as: 1. creating a duty on the Health Secretary to ensure that all those providing health and social care cause zero avoidable harm; 2. requiring integration in health and social care by way of a single identifier and a duty to undertake data sharing where it is for the patient’s care and is in their best interests; and 3. providing health and social care regulators with a clear responsibility to achieve public protection. The Bill received Royal Assent on 26 March 2015. / read more

The United States Office of the National Coordinator for Health Information Technology (‘ONC’) published ‘Connecting Health and Care for the Nation - A Shared Nationwide Interoperability Roadmap’ in October. The initial draft released in January 2015 received over 250 comments, which were incorporated into the finalised version of the ONC’s Interoperability Roadmap, which sets out a clear path that draws in the collaboration of the various public and private sector stakeholders who will be responsible for building, expanding and using the interoperable health IT infrastructure. Steven D. Gravely and Erin S. Whaley of Troutman Sanders LLP, discuss the context surrounding the ONC’s Interoperability Roadmap and the ONC’s vision for a ‘learning health system.’ / read more

Andrea Tithecott and Christina Sochacki of Al Tamimi & Company, continue in this series of articles to explore the topic of eHealth - and in particular telemedicine services - in the Gulf countries. In this final instalment, Andrea and Christina consider some of the legal issues, beyond licensing, relating to telemedicine services. / read more

The healthcare sector in the UK, although so far not targeted on as significant a scale as its counterpart in the US, is attractive to cyber criminals given the value of health data. Both the UK government and EU authorities are taking action on cyber security through initiatives such as the UK’s Cyber Essentials scheme and at a legislative level, predominantly through the proposed EU Network and Information Security Directive. Simon Shooter of Bird & Bird explains why the UK’s NHS can be considered a major cyber target, what healthcare operators can do in terms of improving cyber security, and what’s upcoming on the legislative horizon. / 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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