Digital Health Legal

Volume: 4 Issue: 12
(December 2017)


News

The US Food and Drug Administration (‘FDA’) announced on 13 November 2017 that it has approved Abilify MyCite, the first drug in the US with a digital ingestion tracking system, a development that has caused excitement due to the potential commercial and health implications, but has also caused concern relating to possible privacy issues. / read more

The Florida Supreme Court ruled, on 9 November 2017, in Emma Gayle Weaver, etc. v. Stephen C. Myers, M.D., et al., that the right to privacy under Florida’s Constitution does not end upon an individual’s death. The ruling concerned a medical malpractice claim brought by Weaver as an individual and as representative of the estate of her late husband. In particular, Weaver challenged the constitutionality of the 2013 amendments to Sections 766.106 and 766.1065 of the Florida Statutes (‘the Amendments’), which relate to disclosures that should be made as part of medical negligence actions, on the basis that these violated the right to privacy under Florida’s Constitution. The Florida Statutes and the Amendments required Weaver to authorise the release of her husband’s protected health information (‘PHI’), which she alleged was irrelevant to the case, as well as to consent to secret, ex parte interviews between the health providers and the defendant or his legal representatives, in order to proceed with the medical negligence action. / read more


Features

In an attempt to help tackle the addiction crisis in the US, on 26 October 2017 President Trump declared the opioid crisis a public health emergency; the declaration has a number of implications including around expanded access to telemedicine. While there is significant interest from stakeholders in expanding telemedicine use to help tackle addiction, there are however some concerns, including as to whether the expansion of access to telemedicine under the declaration is in conflict with existing federal law. René Quashie, Member at Cozen O’Connor, describes the background to the crisis, what the declaration means for telemedicine, and the issues being raised. / read more

Professor Sir John Bell’s industry-led industrial strategy for the UK’s life sciences sector was published on 30 August 2017 and puts forward proposals to be considered by the Government and used to work towards a sector deal between Government and the life sciences sector, particularly in light of the imminent changes to be brought about by Britain’s exit from the European Union. Paul Ranson, Consultant at Morgan Lewis, dissects Sir John Bell’s industrial strategy in the context of the UK’s departure from the European Union. / read more

Following a report carried out by French economist and public policy expert Jean Pisani-Ferry, the French Government presented on 25 September 2017 the outline of its investment strategy for 2018-2022. Of the €57 billion budget announced by the Government, €4.9 billion is intended to be spent on the digital transformation of the French health system and for the creation of a digital health ecosystem in France. Christophe Fichet, Benjamin Znaty and Edwige Lataste of Simmons & Simmons discuss the proposals put forward in the Pisani-Ferry report, which provide valuable insight into what the digital health roadmap in France might look like for the years ahead. / read more

In light of the UK Department of Health (‘DOH’) publishing its 2017/18 Data Security and Protection Requirements on 30 October 2017, and the National Audit Office (‘NAO’) publishing its report on the findings of its Investigation: WannaCry cyber attack and the NHS on 27 October 2017, Stefania Littleboy of Mishcon de Reya looks at the lessons learned from major UK data breach incidents in 2017 and discusses the potential implications of the two aforementioned documents for the healthcare sector. / read more

Germany may have acquired a reputation for having a challenging environment with which to operate a digital health business, with critics pointing to issues such as a strict data protection regime and the nature of the German health insurance sector. In this article however, Marc L. Holtorf, Partner and Head of German Intellectual Property and Life Sciences at Pinsent Masons Germany LLP, presents a more positive view of the status of digital health in Germany, and looks at some of the initiatives being taken by the German federal Government to support digital health. / read more

NHS Digital, alongside the Good Things Foundation, a UK-based digital inclusion charity, is set to roll out over the next three years the Widening Digital Participation programme, which aims to tackle digital exclusion in order to better enable access to digital healthcare and health information. Nicola Gill of NHS Digital outlines how the programme will work and the Pathfinder projects announced so far. / read more

Libby Baney, JD, Executive Director of the Alliance for Safe Online Pharmacies (ASOP Global), a non-profit organisation dedicated to combatting illegal online pharmacies and counterfeit medicines, provides indepth insight into the work of ASOP Global to combat illegal online pharmacies and counterfeit medicines and its focus for the year ahead. / 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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