Digital Health Legal

Volume: 3 Issue: 7
(July 2016)


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 at some point 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

China’s State Council promulgated an ‘Opinion on the Promotion and Standardisation of Application and Development of Big Data for the Healthcare Industry’ dated 24 June 2016, which aims to promote the development of big data within healthcare. / read more

The European Commission launched a survey on the safety of apps and other non-embedded software on 9 June 2016, which seeks stakeholders’ views in order to gain a better understanding of the possible risks and problems posed by such technologies in order to define future EU policies to ensure health, safety and consumer protection in the digital arena. / read more

The UK’s Department of Health has launched a public consultation on the proposed data security standards and new consent/opt-out model for data sharing in the NHS and social care, which was set out in Dame Fiona Caldicott’s Review of Data Security, Consent and Opt-Outs, published on 6 July 2016. / read more

The US HHS Office for Civil Rights (‘OCR’) released on 11 July 2016 new Health Insurance Portability and Accountability Act (‘HIPAA’) guidance relating to ransomware, in the light of a reported increase in such attacks, including on hospitals. / read more

The Office of the National Coordinator for Health Information Technology (‘ONC’) released on 19 July 2016 its report to the US Congress, ‘Examining Oversight of the Privacy & Security of Health Data Collected by Entities Not Regulated by HIPAA’ (‘Report’), which details the possible risk to protected health information (‘PHI’) resulting from entities not covered by the Health Insurance Portability and Accountability Act 1996 (‘HIPAA’). / read more


The recent Brexit referendum may have triggered a period of significant legislative and policy flux in the UK. Although healthcare has long remained an area in which EU Member States (including the UK) have retained a significant amount of sovereignty (as demonstrated by the significant variance of healthcare systems across the EU), the EU plays a very important role in ancillary issues, including medical device regulation, data protection, e-commerce, research and public procurement. It is still too early to say with any certainty what will emerge, and by when, once the UK formally leaves the EU. Any number of arrangements could be envisaged, but by and large the key issue is whether the UK will remain part of the European Economic Area (‘EEA’) - and thus directly subject to most EU law - or whether it will end up in a more arm’s length relationship (an outcome likely to prove more palatable to most Brexit supporters). Phil Bradley-Schmieg and Brian Kelly of Covington & Burling LLP, provide detailed analysis of the uncertainty cast on the eHealth market following the UK’s vote to leave the European Union. / read more

Following the publication of the agreed texts of Europe’s Medical Devices Regulation (‘MDR’) and the In Vitro Diagnostic Medical Devices Regulation (‘IVDR’) on 15 June 2016, Dr Lincoln Tsang, Partner at Arnold & Porter LLP and Erik Vollebregt, Founding Lawyer at Axon Lawyers, provide their immediate reactions to the texts of both Regulations and the provisions that have been included that will directly impact Europe’s eHealth market. / read more

On 7 June 2016, the Code of Conduct on privacy for mHealth apps was submitted for review to the Article 29 Working Party. The Code of Conduct has the potential to support the emerging market for mHealth apps and the customers that entrust their data with them. Hans Graux, Partner at time.lex Law Offices and Editor of the Code of Conduct on privacy for mobile health applications, describes the approach taken to crafting the Code of Conduct, especially relating to the future changes to the European data protection landscape to be brought in by Europe’s General Data Protection Regulation (‘GDPR’). / read more

Telemedicine is recognised and practised in India, yet India’s laws governing medical practice are behind the curve when it comes to innovative uses of IT in the medical sphere, and a number of legal questions remain in relation to telemedicine. Amrutha Bhat of IndusLaw assesses the relevant legal provisions relating to the practice of telemedicine in India and the areas in which law and regulation are found wanting. / read more

Part two of the ‘hateful eight’ of the EU’s General Data Protection Regulation (‘GDPR’) by Erik Vollebregt, Founding Lawyer at Axon Lawyers, provides the final five aspects that will, Erik believes, impact significantly on eHealth. / read more

The advent of high speed internet and telecommunications has made telemedicine possible in Russia. Aiming to overcome geographical barriers and increase access to healthcare services, more medical institutions are using telemedicine. With the growth of IT infrastructure and network speeds, new online telemedicine platforms have been launched over the past few years. Although de facto telemedicine is used in the country, de jure it does not exist, with no regulation specific to telemedicine. This means that a remote diagnosis is not formally recognised and thus a patient cannot be treated based on such a diagnosis. / 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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