Digital Health Legal

Volume: 1 Issue: 6
(July 2014)


The UK Department of Health (DoH) issued a consultation entitled ‘Protecting Health and Care Information: A consultation on proposals to introduce new Regulations’ on 26 June, which includes a proposal to allow organisations to set up ‘accredited safe havens’ (ASH) that will provide a secure environment for identifiable patient data. / read more

The United States Food and Drug Administration (FDA) proposed on 17 June two draft pieces of guidance on companies’ online communication about drugs and medical products; the first concerns the presentation of risk/benefit information on social media and paid search result links, and the second contains recommendations for companies looking to correct misinformation published online by third parties about their products. / read more

The Indian government announced on 4 July a partnership with Facebook to collaborate on health and education initiatives in India, which will leverage the popularity of Facebook in the country. / read more


A holistic view of health - that’s what Apple’s Healthkit aims to provide. Victoria Hordern, privacy and information specialist, and Legal Director at Fieldfisher, discusses Apple’s Healthkit in detail, how it might fit into the regulatory landscape and addresses the important question about who owns and controls the data that individuals share about their health. / read more

The US Food and Drug Administration (‘FDA’) has further clarified its regulatory approach to health IT products, broadening the list of mobile applications that will not be subject to active FDA regulation. In addition to this, in June of this year, the FDA released draft guidance that proposes to subject to enforcement discretion all Medical Device Data Systems, Medical Image Storage devices, and Medical Image Communications devices. Both developments represent a shift in FDA thinking and have subsequently caused some controversy in industry. Yarmela Pavlovic, a Partner at Hogan Lovells, provides detailed analysis of the FDA’s developing stance on health IT products. / read more

The UK’s Medicines and Healthcare Products Regulatory Agency (‘MHRA’) published guidance on medical device stand-alone software, which includes mobile apps, on 19 March 2014. The guidance is designed to help healthcare and software developers determine whether a specific piece of stand-alone software or an app constitutes a medical device. In this roundtable, leading experts share their views on the usefulness of the MHRA’s new guidance and whether we now have clarity on the circumstances in which apps qualify as medical devices.   / read more

At the end of 2013, the Federal Minister for Health announced a panel review into Australia’s Personally Controlled Electronic Health Record (‘PCEHR’) system to consider implementation and uptake issues. The subsequent report, made public in May 2014, puts forward 38 recommendations to address the issues identified, which includes the recommendation that the PCEHR system should be transitioned to an opt-out model. Michael Morris and Phil O'Sullivan of Allens assess the review panel’s recommendations and the Federal Government’s impending response. / read more

Companies have already launched into the French eHealth market; however, there remains only a partial legal framework in France applicable to eHealth. Renaud Bouvet and Etienne Minvielle, of the French School of Public Health, and Pierre Desmarais of Desmarais Avocats, discuss the development of eHealth in France and the need for a supranational legislative solution. / read more

An unfortunate consequence of the integration of the Internet of Things (‘IoT’) into the healthcare sphere is an increase in the potential for healthcare systems and devices to be targeted by cyber criminals. S.H. Foss Jr., Chief Operating Officer at live threat intelligence and solutions provider Norse Corporation, Inc., discusses the cyber attacks observed to be targeting this area and what trends have emerged, and provides pointers on moving towards a more secure IoT in the healthcare sector. / read more

Erik Vollebregt, specialist in EU and national legal and regulatory issues relating to medical devices, Partner at Axon Lawyers and member of the eHealth Law & Policy editorial board, examines medical software updates, plugins and add-ons from a legal and regulatory perspective and the problems that may arise in future for software updates that add functionality that significantly changes the performance and safety of the updated device. / read more

The Cyber Essentials Scheme (‘Scheme’)1 is a key plank of the UK’s National Cyber Security Strategy Programme. The Scheme is a set of controls and implementation guidance for basic cyber hygiene against which organisations can achieve different levels of certification. It is intended to be a voluntary standard as opposed to a legal requirement. The Scheme was officially launched on 5 June 2014. It addresses: the level and different types of cyber threat; vulnerabilities, weaknesses and exploits; and cyber incidents and their local and national impacts. The Scheme builds on the UK Government’s ‘10 Steps to Cyber Security,’ particularly five key aspects relating to ISO 27001. By Brian Kelly of Covington & Burling. / 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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