While the French Government has acknowledged the benefits of digital health, French healthcare authorities are still struggling to grasp how to regulate apps and other digital health products. The issues the authorities face, both on the regulatory side and/or on the pricing and reimbursement side, have led to very few digital related innovations or technologies being granted reimbursement thus far, as Alexandre Regniault and Emmanuel Garnier of Simmons & Simmons LLP explain. / read more

On 9 February 2018, the Ministry of Trade, Industry and Energy (‘MOTIE’) of the Republic of Korea (hereafter ‘Korea’) announced the ‘Bio-Healthcare Industry Development Plan Based on Medical Big Data,’ which aims to aid the development of customised medicines and medical devices and support innovative healthcare services by utilising the vast amounts of medical data produced by hospitals. Keun Woo Lee, Partner at Yoon & Yang LLC, discusses the details of the Plan, which aims to create new jobs, reduce medical costs, and improve public health in Korea in response to the challenges presented by the fourth industrial revolution. Keun Woo Lee also sheds light on how the current legislation surrounding medical services and personal health information in Korea will need to change in light of MOTIE’s Plan. / read more

The Danish Ministry of Health, the Ministry of Finance, the Danish Regions, and Local Government Denmark published a new digital health strategy entitled ‘A Coherent and Trustworthy Health Network for All - Digital Health Strategy 2018-2022’ (the ‘Strategy’) in January 2018, which aims to create a health system for patients that is trustworthy, coherent and personalised. Dan Ermose, Associate Partner at Accura Advokatpartnerselskab, discusses Denmark’s new Strategy within the context of the current state of digital health in the country and the imminent legal changes being adopted in Europe, and shares his thoughts on the challenges ahead - despite Denmark being at the forefront of eHealth - in realising more consistent use of digital health. / read more

Healthcare apps present unprecedented opportunities to transform the way healthcare is delivered, but these new media for delivering healthcare bring with them novel risks and challenges. The speed at which this area of healthcare is growing points to future claims for harm caused to patients and issues of risk and responsibility that are already intricate in clinical negligence litigation, and which are potentially made more complicated when traditional healthcare is shifted into the digital arena. Dan Morris, Partner at Bevan Brittan LLP, in this article discusses the evolving lines of responsibility relating to health apps when an end user suffers harm, and that whilst app developers might primarily be concerned with trying to shoehorn an app into a particular regulatory category, they should not assume that a particular designation will protect them from ultimate responsibility for fault where harm arises. Dan also shares his reaction to the US Food and Drug Administration’s (‘FDA’) determination that Matis’s My Baby’s Beat app is a non-medical device. / read more

The UK’s Care Quality Commission (‘CQC’) published a report on ‘The state of care in independent online primary health services’ on 23 March 2018, which presents the findings from a programme of inspections carried out by the CQC into online primary health services in England and which puts forward a set of next steps for improving online care. The CQC states in the report that it has learned a lot about the strengths and limitations of primary health care provided online and it accepts that the “advancement in technology has outpaced the evolution of the regulations.” / read more

Israel’s Prime Minister Benjamin Netanyahu announced on 25 March 2018 the investment of NIS 1 billion in digital health and the launch of a new Big Data Health Project that aims to provide researchers, developers and global companies with the ability to access the health data of almost nine million Israeli citizens currently held by Israel’s four Healthcare Maintenance Organizations (‘HMOs’) in order to aid the development of preventative and personalised medicine. Netanyahu’s speech, made during his weekly Cabinet meeting, stressed the importance of each Israeli citizen’s consent to sharing their personal health data as an absolute right, whilst commenting on the immense value of such a healthcare database at global level and that he has already met with many global companies that are interested in coming to Israel to be involved in the Project. / read more

On 1 February 2018 the UK Department of Health and Social Care (‘DHSC’) published its independent report entitled ‘Lessons learned review of the WannaCry Ransomware Cyber Attack’ (the ‘Report’). The stated aims of the Report were to analyse the lessons learned, assess the actions taken to date and to make clear recommendations on what further measures are required to ensure the entire health and social care system is as robust as it can be in reducing the risk and impact of a future cyber attack. Dan Hyde, Partner at Penningtons Manches, in this article examines the Report, providing insight into the background and context of the attack before assessing the Report’s findings. / read more

The European Commission intends to support and enable the deployment of eHealth services among EU Member States, particularly cross border eHealth information services (‘CBeHIS’). This has led to a regulatory framework for the implementation of CBeHIS with regard to ePrescriptions and patient summaries: the eHealth Digital Service Infrastructure (‘eHDSI’). Evelyn Shulz and Susann Jahn of Noerr LLP provide commentary on the eHDSI and the requirements Member States must implement in order to ‘go live.’ / read more

On 30 January 2018, three major companies representing over 1.2 million employees announced their plans to form a nonprofit company to embark on an ambitious venture to take back control over their employees’ healthcare costs and wellbeing as Sheryl Tatar Dacso, Partner at Seyfarth Shaw LLP and member of the Digital Health Legal Editorial Board, explains. The three companies - Amazon, Berkshire Hathaway and JP Morgan Chase - bring much more to this venture than just their employees. What they bring to the market is a new and disruptive approach to the delivery of and payment for healthcare services and products, leveraging the technology and innovation of Amazon, the capital management skills of Berkshire Hathaway and the financial prowess of JPMorgan Chase. / read more

Singapore’s Ministry of Health has issued a consultation on its draft Healthcare Services Bill (‘Draft HCS Bill’), which is intended to replace the current Private Hospitals and Medical Clinics Act (‘PHMCA’). Driven partly by the way in which digital healthcare solutions have disrupted the healthcare sector, the Draft HCS Bill will have a number of implications for the digital health sector, such as in regards to electronic health records. Benjamin Gaw, Director at Drew & Napier LLC, takes a look at these implications, in many cases outlining the current position under the present legislation before exploring how the Draft HCS Bill intends to change the situation. / read more