On 22 May 2018, Singapore’s Health Sciences Authority (‘HSA’) announced some changes to its medical devices legislation. The changes announced are designed to enable faster market access for certain types of medical devices and to clarify approval practices and policies. The changes came into force on 1 June 2018 and were conceived after extensive engagement with the medical devices industry to address the various needs of different business models in the medical devices sector, and balance faster market access to innovations with consumer health and safety. Thomas Griffiths and Desmond Tan of Davies Collison Cave Asia, discuss the changes to medical devices legislation in Singapore and the impact on manufacturers. / read more

By the time you read this article, it may well be outdated. And that’s a good thing for digital health companies. Changes in digital health policies have been coming at lightning speed from Congress and the US Food and Drug Administration (‘FDA’). With the continued explosion of software and software-controlled medical devices, including the growing use of machine learning and artificial intelligence to develop tools to support and even enhance the practice of medicine, the FDA has acknowledged that the existing framework for regulation of medical devices is not entirely suited to this new realm of products. As a consequence, the FDA, with the help of Congress, has been rapidly developing a new paradigm. Yarmela Pavlovic, Kristin Zielinski Duggan, and Suzanne Levy Friedman of Hogan Lovells in this article review some of the recent FDA initiatives in this space, including the Precertification Program, the Medical Device Safety Action Plan and the FDA guidance on Multiple Function Device Products. / read more

A key output from Scotland’s devolution process was the transfer in 1999 of responsibility for the operation of the NHS in Scotland to the Scottish Government. From a digital health perspective that move created a fertile environment within which digital health initiatives can benefit from the structure of the NHS, whilst operating at a scale that is more manageable than that found in England. With a population of just under 5.3 million and a large geographical area within which health services are required, Scotland puts a real focus on digital health, a policy underscored by the issuance on 25 April 2018 of Scotland’s Digital Health and Care Strategy (the ‘Strategy’). In this article, Matthew Godfrey-Faussett, Partner at Pinsent Masons and Member of the Digital Health Legal Editorial Board and Stuart Miller of Outlaw.com, identify the key elements of the new Strategy that will underpin the expansion of digital health usage in Scotland. / read more

Massive data breaches. Threats to medical devices. The Internet of Persons. Healthcare entities are all too familiar with the rising cyber threat. But they are also familiar with the complex array of laws and regulations in the United States that attempt to address the threat and the potentially significant compliance costs and risks caused by that complexity. The US Court of Appeals for the Eleventh Circuit’s recent and long-awaited decision in LabMD v. Federal Trade Commission, which trimmed the sails of one of the primary regulators of the healthcare information security landscape, may thus appear to some, at first blush, to be a necessary corrective. Yet closer inspection shows that the Eleventh Circuit’s decision raises more questions than it answers - and that its true implications will only become clear once we see how federal regulators, the courts, and perhaps Congress respond, as Christopher Fonzone and Kate Heinzelman of Sidley Austin LLP explain. / read more

Tomáš Rybár and Ivan Kolenič of Čechová & Partners, in this article, provide insight into the development of eHealth in Slovakia and assess the progress of the eHealth system that began operation on 1 January 2018. / read more

Nilaya Varma, Partner and Head of the Government and Healthcare Practice at KPMG, discusses in detail the ‘Ayushman Bharat’ programme, which aims to transform healthcare coverage and access to healthcare in India. / read more

Artificial intelligence (‘AI’) has the potential to transform our health sector, it promises to advance how we research, how we diagnose, and how we ultimately treat patients. What of its accompanying regulation? Can the existing law of agency, liability, and data protection accommodate such a technological change? The recent House of Lords report, ‘AI in the UK: ready, willing and able?’ touches on such questions. Coming to no definitive conclusion, the report digests conflicting opinion: some think AI will constitute a new paradigm for health law, others envision a series of limited, iterative changes. Who’s right? Johan Ordish, Senior Policy Analyst (Law & Regulation) at PHG Foundation, a health policy think tank part of the University of Cambridge, argues in this article that the most pressing concern is not any unique challenge AI might pose but rather the gaps that already exist in our laws of liability and medical devices. / read more

On 1 January 2018, Latvia introduced the mandatory use of eVeselība (‘eHealth’ in Latvian), the IT system covering major aspects of the healthcare process in the country. Indriķis Liepa, Partner at Cobalt, reviews the new system now that several months have passed since use was mandated, assessing the system’s ease of use, whether any benefits have been realised for the healthcare industry and the criticisms publicly voiced about the new system. / read more

With the 2013-2018 Belgian E-Health Programme due to expire at the end of this year, the time has come to consider the most recent steps that have been taken in the area of digital health and set out in broad terms the challenges that remain for digital health in Belgium, as Annabelle Bruyndonckx and Vladimir Murovec of Simmons & Simmons LLP explain. / read more

In February 2018 the Irish Government published its National Development Plan for 2018-2027 as part of Project Ireland 2040. The Plan includes various healthcare initiatives that have been welcomed by stakeholders in the sector, such as investment in eHealth, and particularly ICT infrastructure, to enable the integration of services and the flow of information across and within various care settings. Adam Finlay, Partner at McCann FitzGerald, explains the latest health reform initiatives in Ireland. / read more