Digital Health Legal

Volume: 1 Issue: 11
(December 2014)


The National Information Board (NIB) published its ‘Personalised Health and Care 2020’ policy paper on 13 November, which sets out a ‘Framework for Action’ on how data and technology can be used to reform healthcare delivery in England; plans of which include the ‘regulation, accreditation and kitemarking’ of apps. / read more

Data from a Fitbit wearable device is to be used for the first time in a personal injury case, after the plaintiff instructed McLeod Law firm to have the data processed in an attempt to illustrate to a Calgary court the detrimental effect an injury has had on her lifestyle. / read more

The UK’s Information Commissioner’s Office (ICO) launched an informal survey in November into the current practices relating to the use of data-enabled medical devices and apps. / read more


On 13 November the National Information Board (‘NIB’), a body drawn from 19 NHS and local government agencies, published a ‘Framework for Action’ entitled ‘Personalised Health and Care 2020: Using Data and Technology to Transform Outcomes for Patients and Citizens.’ The document must be read in conjunction with NHS England’s ‘Five Year Forward View,’ published on 23 October. Simon Phillips, a Partner at Bird & Bird examines in this article the contents of the Framework and outlines its vision for the way that innovative use of data and technology could reform how healthcare is delivered in England. Simon also shares his concerns that the Framework, despite its laudable ambitions, is light on how these plans will be implemented, and that the experience of the last decade of national health IT initiatives has taught us that this is the very area where the NHS is most suspect. In Simon’s view, the plans must therefore be reviewed with some skepticism. / read more

The Health Information Technology for Economic and Clinical Health Act (‘HITECH Act’) was passed by the US Congress back in 2009, with the aim of encouraging greater adoption of electronic health records (‘EHRs’). The HITECH Act provides financial incentives for hospitals and certain healthcare professionals who become ‘meaningful users’ of EHRs. Taking stock of developments since the passing of the HITECH Act, it appears that there is both good news and bad with regard to the impact of the HITECH Act on EHR take-up, as René Quashie of Epstein Becker & Green explains. / read more

This year’s EHI Live conference, held at the Birmingham NEC on 4-5 November, brought together much of the UK’s eHealth sector to mull over the latest initiatives, opportunities and hurdles faced by the sector. Based on the talks and technology demonstrations on show, much of the UK’s eHealth sector seems preoccupied with the transition to paperless, ‘big data’-related privacy fears, and tentative experiments with social media. More advanced technology, such as clinical decision support software, smart medical devices, cloud computing, and even the classic example of eHealth’s promise, telemedicine, were less prominent. There are many possible reasons for why this might be. One of those might be regulatory uncertainty; some IT providers and their potential customers (both in the NHS and private sector) seemed to suffer from significant discomfort and lack of familiarity around the legal and regulatory framework within which they were operating. It is possible that fear and uncertainty may be stunting conversations and causing many potential users to needlessly shy away from exploring the value of these technologies. By Philippe Bradley-Schmieg of Covington & Burling LLP. / read more

Erik Vollebregt, specialist in legal and regulatory issues relating to medical devices, Partner at Axon Lawyers and member of the eHealth Law & Policy editorial board, takes a look at the lack of specific cyber security requirements for medical devices in Europe and draws comparisons with recent developments in the US. / read more

Petra Wilson and Sara Webber of the International Diabetes Federation and Isabelle Andoulsi of GLS Attorneys at Law provide a breakdown of the legal challenges to the adoption of mobile health (‘mHealth’) in Europe, which has the potential to revolutionise diabetes care and prevention. / read more

The Operational Program ‘Digital Poland’ for 2014-2020, to be financed by European Funds, was submitted for approval to the European Commission (‘EC’) on 30 October 2014. The program has already been discussed within the EC and the version submitted has been agreed, therefore it is expected that approval will be just a formality. The program addresses the digitalisation of healthcare and the facilitation of telemedicine. By Sylwia Paszek of Wardynski & Partners. / read more

The last two years have been marked by unprecedented scrutiny of financial relationships between manufacturers and healthcare professionals. Both the US and France have imposed sweeping reporting and disclosure requirements in an effort to provide transparency and enable the public to make informed treatment decisions and assess possible conflicts of interest. That being said, a review of the highlights of the two Sunshine Acts demonstrates that transparency is not necessarily the same on one side of the Atlantic as the other. One year after the implementation of the French Sunshine Act, Daniel Kadar of Reed Smith looks back at how compliance has and continues to be a real challenge for global manufacturers. / 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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