Digital Health Legal

Volume: 4 Issue: 3
(March 2017)


England’s Care Quality Commission (‘CQC’) published on 3 March 2017 a warning about risks to patient safety from online healthcare services, following urgent investigations into two online providers; specifically the CQC expressed concern that some online providers may not be checking that medicines are appropriate for consumers before selling them, for example by failing to adequately assess the patient’s symptoms and medical history. / read more

The Council of the EU adopted on 7 March 2017 the latest texts of the draft Regulation on medical devices and the draft Regulation on in vitro diagnostic medical devices, marking another milestone towards the coming into force of both regulations. Political agreement on the reforms was reached by the Council and the EU Parliament last summer, with the latest texts reflecting comments by MEPs; the Parliament is now set to vote on adopting the Regulations in April this year before publication in the official journal, with the Regulations thus set to come into force in May 2017. / read more

The UK Information Commissioner’s Office (‘ICO’) announced, on 28 February 2017, that it has fined HCA International Ltd £200,000 for failing to keep fertility patients’ personal information secure when outsourcing to a sub-contractor. / read more


In one of the latest developments in the artificial intelligence (‘AI’) revolution, the UK’s NHS has begun to test the AI app Babylon as a complement to its NHS 111 non-emergency service. While AI has significant potential, for example as a means to cut costs for organisations like the NHS, it is not without its attendant legal risks, which include liability for misdiagnoses and data protection compliance. Selina Hinchliffe and Mark Nichols of Browne Jacobson detail the legal issues surrounding the use of AI in healthcare and how such risks might be mitigated. / read more

With an eye on the healthcare space, especially within the UK’s NHS, Kumar Jacob, CEO at Mindwave Ventures Limited, discusses the state of the current focus on ‘innovation.’ Kumar looks in particular at the role ‘bureaucracy’ - including intellectual property lawyers and infrastructure departments, for instance - can play in facilitating and encouraging innovation, and explains why in his view it is better that everyone in an organisation works together towards greater innovations. / read more

On 10 January 2017 the European Commission released its draft Privacy and Electronic Communications Regulation, an update on the ePrivacy Directive, which was last amended in 2009. The ePrivacy Regulation contains rules across a number of areas, including direct marketing and processing and storage. Some of the rules contained in the draft Regulation - such as those relating to Privacy by Design and OTT services - will be especially pertinent to eHealth services, meaning that organisations in the eHealth space should carefully consider what the new rules will mean for their business. Valerie Surgenor and Melissa Hendrie of MacRoberts describe the key changes in the draft ePrivacy Regulation and explain its implications for the eHealth sector in particular. / read more

Richard Corbridge, Chief Information Officer of the Irish Health Service Executive and CEO of eHealth Ireland, provides an overview of eHealth Ireland’s ‘vision,’ which includes a range of digital projects, such as e-Prescribing, e-Pharmacies and cloud computing. Richard talks in particular detail about eHealth Ireland’s e-Pharmacy programme and e-Prescribing, as well as outlining the organisation’s successes in this space so far. / read more

A recent enforcement action by the U.S. Department of Health and Human Services Office of Civil Rights (‘HHS’) against Presence Health has illuminated the importance of timely breach notification, and represents the first enforcement action to date in relation to untimely breach reporting by a covered entity under the US HIPAA-HITECH Rules. Joan Antokol of Park Legal LLC analyses the lessons to be learnt from the action, including for organisations outside the US that will soon be affected by the EU’s General Data Protection Regulation (the ‘GDPR’). / 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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