Digital Health Legal

Volume: 2 Issue: 10
(October 2015)


Australia’s federal health minister Sussan Ley introduced on 18 September the Health Legislation Amendment (eHealth) Bill 2015, which would amend the country’s Personally Controlled Electronic Health Record (‘PCEHR’) system, renaming it ‘My Health Record’ and creating an automatic opt-in concept, requiring citizens to opt-out of the programme. / read more

A study into apps in the NHS Choices Health Apps Library by Imperial College London, published in the BMC Medicine journal on 25 September, has found inter alia that of 79 apps tested over a six month period, 23 transmitted personal information without protection and four of these sent medical information without encryption. The study also raised the concern that 38 apps had a specific privacy policy that failed to mention what information was sent via the internet. / read more

The Precision Medicine Initiative (‘PMI’) Working Group released its report ‘The Precision Medicine Initiative Cohort Program - Building a Research Foundation for 21st Century Medicine’ to the Director of the National Institutes of Health on 17 September, which provides a framework for building a national research group of one million Americans that will form a key component of the Obama Administration’s PMI. / read more


The European Commission (‘EC’) has published a report on the status of the transposition of Directive 2014/24/EU (‘Directive’) on patient rights in cross-border healthcare into the national law of EU Member States (‘MS’). The EC found that, particularly in certain MS, the Directive has not been transposed fully or else obstacles exist around accessibility and reimbursement, for example. Not only does the report provide an update on the progress of the Directive’s implementation, which is of note for eHealth providers, but the EC also raises a number of unresolved questions in the context of the reimbursement of telemedicine services. Dr. Alexander Csaki and Clarissa Junge-Gierse of Bird & Bird discuss the report’s findings and what this could mean for telemedicine in the EU. / read more

NHS England is moving towards a goal of a paperless NHS at the point of care by 2020, and clinical commissioning groups (‘CCGs’) have been asked to explain how they will move to a paperless system by 2020. These new plans - the latest in a series of initiatives to digitalise the NHS - have now been analysed by health sector information professionals, and as Robin Smith, Health 2.0 Futurist, explains, numerous risks have been identified. / read more

Wearables used to monitor the user’s health and fitness are seeing widespread use, but a perhaps lesser discussed role for wearable devices is their potential to become the future of clinical trials, uploading data from trial subjects as they go about their day. Michaela D. Poizner of Baker Donelson discusses the uses for wearable technology in clinical trials and looks at how regulation could play a part, focusing on the US perspective. / read more

More and more people are using websites to check their symptoms before they decide whether to seek medical attention. The rise of websites providing health information, particularly symptom checking websites, however may create legal issues. Brian Kelly and Raj Gathani of Covington & Burling provide an overview of the potential common law negligence issues under English law. / read more

Ben van Lier, Director of Strategy and Innovation at Centric - which specialises in software solutions, IT outsourcing, business process outsourcing and staffing services - discusses the development of medical cyber physical systems (‘mCPS’) and the emergence of mobile healthcare. Ben argues that essential to this are possibilities for the exchange and sharing of information, which is also known as interoperability of information. / read more

Malta is the smallest EU Member State with just over 420,000 inhabitants in around 316 sq.kms; however it punches way above its weight in regards to the health sector. In fact it was no surprise to us in Malta, but a shock to many others, when the World Health Organisation placed Malta in fifth place in its country rankings of the quality of healthcare systems in 20001. This is not to say that our health system is perfect, but the actual overall service is good, caring and effective. / read more

Andrea Tithecott and Christina Sochacki of Al Tamimi & Company examine recent issues around the regulation of telemedicine services in the Gulf countries. In this first instalment of a two-part article on eHealth in the Gulf countries, Andrea and Christina discuss issues relating to telemedicine licensing. / 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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