Digital Health Legal

Volume: 4 Issue: 1
(January 2017)


UK Prime Minister Theresa May announced £67.7 million of funding for digital mental health services in a speech at the annual Charity Commission lecture in London on 9 January 2017, outlining plans to rapidly expand the treatment of mental health by investing in and expanding digital mental health services. The Government’s press release accompanying the speech states that digitally assisted therapies have already proved successful in other countries and that the Government will speed up delivery of the digital mental health funding package ‘so that those worried about stress, anxiety or more serious issues can go online, check their symptoms and if needed, access digital therapy immediately rather than waiting weeks for a face-to-face appointment.’ / read more

The Organisation of Economic Co-operation and Development (‘OECD’) published a report on New Health Technologies: Managing Access, Value and Sustainability on 16 January 2017, which discusses the need for an integrated approach to managing health technology to mitigate clinical and financial risks and provides a set of recommendations for policymakers to embrace the opportunities presented by health technologies whilst appropriately managing the risks. The OECD’s report analyses the progress made through the adoption of health technologies so far and the potential future impact. / read more


The question of how much the data of an individual is worth is a pertinent one in today’s world - and data relating to an individual’s fitness and wellbeing has the potential to be especially valuable. Organisations such as health insurers have an obvious need for data about their customers, and this data could assist insurers in offering insurance at a reduced premium if for example the customer’s data suggests that the customer is living a healthy lifestyle. Ensuring that any such deals are legally compliant is vital, as Victoria Hordern, Counsel at Hogan Lovells, explains. / read more

When it comes into effect on 25 May 2018, the EU’s General Data Protection Regulation (‘GDPR’) will create a new ‘data portability’ right. This requires companies to transmit personal data directly to a competing company at the request of the individual, and could be applied in the healthcare sector; for instance, theoretically, the right could allow patients to instruct hospitals to transfer their records to another hospital, or to instruct an online healthcare service to move medical records to a competitor. However, the right will trigger complex questions in some cases, and the Article 29 Working Party (‘WP29’) has now issued guidance on the meaning and interpretation of this right. Hans Graux of time.lex discusses the data portability right in the context of healthcare and analyses the WP29’s guidance. / read more

On 13 December 2016, H.R. 34, the 21st Century Cures Act (the ‘Act’), was signed by President Obama. The Act tackles a diverse array of healthcare innovation challenges and opportunities, including funding and process improvements for crucial federal agencies that hold authority to review and approve new drugs, biologics, and medical devices in the US, as Brian Scarpelli, Senior Policy Counsel at ACT | The App Association, explains. / read more

As part of the European Commission’s initiative within its Digital Single Market (‘DSM’) Strategy to focus on and boost eHealth initiatives, a public consultation on the safety of apps and other non-embedded software ran from 9 June until 15 September 2016 (‘the Consultation’). A summary report of the Consultation was published on the Digital Single Market website on 14 November 2016. Marc Martens, Maria-Paz Martens and Nicolas Carbonnelle of Bird & Bird examine the summary report and how the safety of apps and other non-embedded software fits into the Commission’s Digital Single Market Strategy. / read more

In October 2016 the Texas Medical Board dropped its appeal of the refusal by the US Court of Appeals for the 5th Circuit (the ‘Court’) to dismiss telehealth company Teladoc’s case against the Board, in a dispute about the passing of what Teladoc considered anti-telemedicine regulations by the Board. Julian Rivera and John Ferguson of Husch Blackwell LLP discuss the reasoning behind the appeal being dropped, the continuing battle between Teladoc and the Board, and the actions of groups in Texas who are looking at developing new regulations relating to the practice of telemedicine in the state. / 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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