Digital Health Legal

Volume: 4 Issue: 4
(April 2017)


The major challenges created by Brexit could create additional opportunities for the providers of digital health solutions, thinks Matthew Godfrey-Faussett, Partner at Pinsent Masons LLP. “The predicted reduction in the number of health and social care staff recruited from EU27 countries prior to and after Brexit, can be expected to force care providers to put greater emphasis on the use of technology to help address at least some of the resource gap,” said Godfrey-Faussett. “The business case for keeping patients with chronic conditions at home for longer, supported by remote monitoring facilities, should become ever more compelling.” / read more

In late March 2017 two determinations were handed down by the Australian Privacy Commissioner (LA & Department of Defence (Privacy) [2017] AICmr 25 and LB & ComCare (Privacy) [2017] AICmr 28), both relating to the accidental unauthorised disclosure of health information. / read more


The Medical Devices Regulation (‘MDR’) and In Vitro Diagnostics Regulations (‘IVDR’), which aim to improve the safety of medical devices for the benefit of patients while preserving timely access to innovative healthcare solutions, have been established in final text following adoption by the EU Council on 7 March 20171. Both regulations will have a profound impact on the eHealth industry because they regulate many aspects of the provision of eHealth services and the underlying devices and software. Compared to the current Medical Devices Directive (‘MDD’) and In Vitro Diagnostics Directive (‘IVDD’), the new regulations mark a quantum leap forward in the regulation of eHealth related functionality with many consequences for the industry, requiring companies that produce medical devices for eHealth to step up their regulatory game considerably. Erik Vollebregt, Partner at Axon Lawyers and member of the Digital Health Legal Editorial Board, often starts presentations and discussions concerning the regulations with the Lord of the Rings paraphrase “One does not simply walk into the MDR/IVDR,” which Erik explains in this article is not an understatement. / read more

With the large increase in both the number and diversity of healthcare providers offering various forms of telemedicine services to US patients, driven for example by the positive reaction telehealth services are receiving from consumers, the legal and regulatory issues around telehealth have been brought to the fore. A key issue in this space is potential liability exposure, with Medical Professional Liability (‘MPL’) the primary liability exposure for the majority of healthcare providers. Here, René Quashie, Member at Cozen O’Connor, and Larry Hansard, Regional Managing Director, Healthcare, at insurance firm Arthur J. Gallagher & Co., discuss the emergence of telemedicine into the mainstream in the US and the legal issues surrounding telehealth, with an emphasis on MPL. / read more

On 3 March 2017, a joint statement was made by the four UK regulators: the Care Quality Commission (‘CQC’), the General Medical Council (‘GMC’), the General Pharmaceutical Council (‘GPhC’) and the Medicines and Healthcare products Regulatory Agency (‘MHRA’), which are respectively responsible for regulating healthcare, the medical and pharmaceutical professions, and medicines and medical devices. The joint statement reminds providers and healthcare professionals that they should follow professional guidelines to ensure online clinical and pharmaceutical services are provided safely and effectively to the general public. Dr Lincoln Tsang, a Partner at Arnold & Porter Kaye Scholer LLP, specialising in regulatory, compliance and enforcement matters concerning the life sciences sector, assesses the latest developments relating to the safety of online primary care in the UK and the CQC’s move to bring forward a programme of inspections prioritising those services it considers as potentially presenting a significant risk to patients. / read more

The UK Information Commissioner’s Office (‘ICO’) closed on 31 March 2017 the consultation on its draft guidance on its approach to consent under the EU General Data Protection Regulation (‘GDPR’). Crucially, as the ICO clarifies in its draft guidance, the obligations laid out under the GDPR set a higher standard for obtaining consent than currently in place under the Data Protection Directive. Robert Bond and Constance Crawford of Bristows take a look at the ICO’s approach to consent under the GDPR and the implications for digital health firms. / 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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