Digital Health Legal

Volume: 1 Issue: 7
(August 2014)


Germany’s Federal Health Minister Herman Gröhe announced on 31 July that the German government is to create an eHealth Council, which will aim to remove barriers to eHealth, improve the interoperability and information exchange between health IT systems and propose improvements to the legal framework around eHealth. / read more

The EC issued an updated version of its ‘Manual on Borderline and Classification in the Community Regulatory Framework for Medical Devices,’ on 30 July, which includes a new section on borderline classification of software and mobile apps. / read more

The European Society of Medical Oncologists (ESMO) set forth in a paper on 29 July its concerns about the proposed EU data protection Regulation’s effect on clinical research and cancer registries. Amendment 191 requires subject consent for health data processing to be ‘given for one or more specific and similar researches;’ the ESMO argues that this could be interpreted as requiring ‘specific’ consent for each research matter the data is used for. “Any consent given by a data subject is purpose-limited: the consent will no longer be valid when it is no longer necessary for the purposes it was collected for,” said Valerie Surgenor, Partner at MacRoberts. / read more


For many years now, the medical device industry has been awaiting specific guidance from the Food and Drug Administration on the use of social media and other interactive platforms in the marketing and promotion of medical devices. The FDA has now issued three important guidance documents, which together provide much needed insight into some key issues that have been holding medical device companies back from taking full advantage of social media platforms, as Jennifer Agraz Henderson, Counsel at Hogan Lovells US LLP, explains. / read more

In their recent report, ‘Patient empowerment: better quality, more sustainable health services globally,’ six health-based All Party Parliamentary Groups looked at what the UK could learn from abroad about patient empowerment and what the UK could be doing to empower patients in other health systems. By Bridget Hughes of Kingsley Napley. / read more

David Houlding, Senior Privacy and Security Researcher at Intel Labs, and Alice Borrelli, Director of Global Health Policy at Intel Health, discuss the Internet of Things revolution in healthcare, the privacy and security concerns that follow when healthcare workers are empowered with information power tools and how those risks can be mitigated. / read more

Recently large tech companies have been virtually lining up to announce1 their foray into the digital health space. Industry analysts have long suspected that an incumbent industry with a strong customer base could come in and disrupt the nascent mHealth sector. Retail, fashion, financial, and ISP companies have all been considered potential disrupters. Now it appears the information technology titans have determined this is the time to strike. By Stephen Graham of Fenwick & West LLP. / read more

In June 2014, the UK Department of Health published its consultation, ‘Protecting Health and Care Information: A consultation on proposals to introduce new Regulations.’ One proposal featured in the consultation would introduce ‘accredited safe havens,’ which would allow organisations to store identifiable patient data securely. Margaret Tofalides and James Cassidy of Clyde & Co LLP examine the proposal and the concept of the ‘accredited safe haven.’ / read more

Neil Jordan, General Manager, Worldwide Health at Microsoft Corp., acts as chief strategist for the organisation’s health industry initiatives worldwide, including defining and articulating the Microsoft vision for the future of healthcare. In this article Neil explains the importance of cloud computing for the improvement of care globally and how Microsoft is helping to build the trust necessary to diminish legitimate privacy and security concerns. / read more

Erik Vollebregt, specialist in legal and regulatory issues relating to medical devices, Partner at Axon Lawyers and member of the eHealth Law & Policy editorial board, assesses the situation in Europe in regards to unannounced audits for standalone software medical devices, how companies can prepare and why they should not be ignored. / read more

The right to health is an almost universally accepted human right. The desire for personal privacy is also fundamental in most cultures, but as a human right it is open to much greater interpretation. In the UK, for example, there is currently no freestanding right to privacy at common law, but personal privacy is often contested as a basic right in courtrooms. By Phil Allen, EMEA Director of Sales, Security/Identity and Access Management at Dell. / 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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