Digital Health Legal

Volume: 3 Issue: 6
(June 2016)


The US Food and Drug Administration (‘FDA’) published on 16 May 2016 draft guidance on using electronic health record (‘EHR’) data in clinical investigations, which aims to facilitate the use of EHR data in clinical trials and promote the interoperability of EHRs and systems supporting such trials. / read more

The Netherlands presidency of the EU Council and representatives of the Parliament reached political agreement on the proposed Medical Devices Regulation and the In Vitro Diagnostics Regulation on 25 May 2016. The two draft Regulations aim to guarantee the safety of medical devices and in vitro diagnostic medical devices, whilst allowing patients to benefit from innovative healthcare solutions in a timely manner. Both draft Regulations are still to be formally approved by the EU Council’s Permanent Representatives Committee (‘PRC’) and the Parliament’s Committee on Environment, Public Health and Food Safety (‘CFS’). / read more

The UK Government put forward on 18 May 2016, via the Queen’s Speech, a proposed Digital Economy Bill, which features measures relating to broadband access and data sharing across the UK, likely to have implications for eHealth. / read more

A Code of Conduct for mobile health (‘mHealth’) privacy was finalised and submitted to the EU Article 29 Working Party (‘WP29’) on 7 June 2016, following several months of work by an industry team facilitated by the European Commission. / read more

The Federal Trade Commission ('FTC') announced, on 8 June 2016, that Practice Fusion, Inc. agreed to settle charges that it publicly disclosed consumers' private information without adequately informing them about how it uses, maintains, and protects the privacy and confidentiality of the information collected, as well as for failing to obtain consumers' consent ('the Settlement'). Michael Daugherty, President & CEO of LabMD, said, "This is another example of government demanding perfection by targeting a small company who does not have the resources to fight. This is not a win, it is a surrender. They have used Practice Fusion as an example to scare other companies into compliance. There are issues when small medical organisations have only two choices; fight and die, or surrender and live." / read more

The implications of the UK’s vote to leave the European Union, on 23 June 2016, could have significant implications on the development of eHealth in the UK. The UK is now facing a lot of uncertainties and will enter into negotiations about divestiture from the EU. During that process new treaties may be introduced to replace instruments of the internal market. / read more


The Peter L. Reichertz Institute for Medical Informatics has conducted a comprehensive study of the German market for mobile health (‘mHealth’) applications, which was published by the German Federal Ministry for Health on 25 April 2016. The study covers a number of areas but perhaps most crucially finds that the German mHealth market is underdeveloped; the authors make recommendations aimed at improving this state of affairs, as Dr Alexander Csaki and Clarissa Junge-Gierse of Bird & Bird explain. / read more

In late April 2016, the European Commission (‘EC’) announced a new plan to stimulate the development of Europe’s high tech industries1. It hopes to help boost industry revenues by an estimated €110 billion a year, across a range of sectors including eHealth. / read more

On 5 April 2016, the Federal Trade Commission (‘FTC’) released new Guidance for developers of mobile health applications to help health app developers comply with the Federal Trade Commission Act (‘FTC Act’) by building privacy and security into their apps, and provided a new web-based interactive tool for developers of health-related mobile apps, which is designed to help the developers understand what federal laws and regulations might apply to their apps. Lynn S. Scott and Sidney S. Welch of Polsinelli PC detail the recommendations made by the FTC in its Guidance, and discuss the uses - and limitations - of the interactive tool. / read more

The EU General Data Protection Regulation (‘GDPR’) will apply from 25 May 2018, which means that there is a transitional period of two years for all affected companies to get their houses in order. The GDPR is intended to provide a modern regulatory framework for the collection and processing of personal data, and therefore will profoundly impact eHealth. In this two-part article, Erik Vollebregt, Lawyer at Axon Lawyers and member of the eHealth Law & Policy editorial board, discusses in detail what he believes are the most significant elements of the GDPR that will impact on eHealth services. The concept of eHealth is used in its broadest sense, so this article is relevant to the eHealth industry, the medical devices industry and for companies that produce devices that involve the processing of personal data concerning health. This article is not intended to provide a comprehensive overview of GDPR requirements, rather it will focus on eight items in the GDPR - three of which will be discussed in part one and five in next month’s issue - that Erik expects will particularly impact the eHealth sector. These are, in succession: informed consent criteria, scope of the concept of personal data concerning health, and the right to be forgotten, followed by impact assessments, profiling requirements, data portability rights, security requirements and export of data to extra-EU jurisdictions in July’s issue. / read more

CRISPR-Cas9 is a revolutionary gene editing technology that enables genomic modifications in a wide variety of organisms and tissues. Dr Sahar Shepperd, Senior Associate at Bristows, discusses the application of CRISPR-Cas9 in editing both human and non-human cells and the ethical issues surrounding such technologies, and provides an overview of the existing EU laws on gene editing. / read more

Many employers will wish to collect employee health information, for example in relation to wellness programmes and biometric security initiatives; wellness programmes are for instance widespread in the US, with employees often offered reductions in health plan premiums in return for participation in such schemes. Edward McNicholas and Anna Spencer, Partners at Sidley Austin LLP, detail the US federal and state law considerations for such employers while noting how EU law might impact on employer compliance. / 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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