Digital Health Legal

Volume: 3 Issue: 9
(September 2016)


The European Commission (‘EC’) published on 8 August 2016 its report, ‘Pharmacovigilance related activities of Member States and the European Medicines Agency concerning medicinal products for human use (2012 – 2014),’ (‘Report’) which focuses on the EU’s pharmacovigilance system and in particular its activities since new legislation was enacted in this area in 2012. The Report finds that a 50% increase in direct reporting by patients has been recorded between 2012 and 2014. / read more

The Future of Privacy Forum (‘FPF’) published guidelines on Best Practices for Consumer Wearables and Wellness Apps and Devices on 17 August 2016, which provides guidance for companies on how to implement practical privacy protections for consumer generated health and wellness data. / read more

The UK’s Medicines and Healthcare products Regulatory Agency (‘MHRA’) issued updated guidance for medical device stand-alone software including apps on 25 August 2016 to help identify the health apps that are medical devices and how to comply with the necessary legal requirements. / read more

China’s Food and Drug Administration (‘CFDA’) released, on 19 August 2016, a draft guidance document on data integrity in clinical trials for consultation. The draft guidance sets out the requirements for Good Clinical Practice relating to data integrity in clinical trials in China and the administrative measures for enforcement.   / read more

US medical device company St. Jude Medical filed a lawsuit on 7 September 2016 against hedge fund Muddy Waters and research company MedSec Holdings, alleging that the latter two’s claims about cyber security vulnerabilities in St. Jude’s cardiac pacemakers and defibrillators are part of a scheme designed to impact St. Jude’s stock rating. St. Jude’s lawsuit refers to the vulnerability claims as ‘false information.’ / read more

The UK Health Secretary Jeremy Hunt announced on 7 September 2016 at the Health and Care Expo in Manchester a number of digital technology measures for use by NHS patients, including the launch of a library of NHS-assessed apps by NHS England; the announcement follows a report, ‘Making IT work: harnessing the power of health information technology to improve care in England,’ (‘Report’) published on 7 September 2016 by the National Advisory Group on Health Information Technology in England, chaired by Professor Robert Wachter. / read more

The US National Institutes of Health (‘NIH’) published its Final Rule on clinical trial information on 16 September 2016 with the aim of increasing the availability of information about clinical trials on the publically accessible database However, there is concern that such disclosures could have a detrimental impact on the company conducting the clinical trial. / read more


‘Safe Data, Safe Care’ is the title of the Care Quality Commission (‘CQC’) Report into data management in the UK NHS. Following their article in the August edition of eHealth Law & Policy on the National Data Guardian’s Review covering data use within the NHS (‘Caldicott3’), Matthew Godfrey-Faussett, a member of the eHealth Law & Policy Editorial Board, and Paul Greaves, both of Pinsent Masons LLP, consider the themes and recommendations within the CQC Report. / read more

The US Food and Drug Administration (‘FDA’ or ‘Agency’) has now finalised its guidance document on its regulatory stance on low-risk general wellness products, having released draft guidance on this subject back in February 2015. Though there are a few notable changes between the draft guidance and this final guidance, the Agency’s general policy direction remains the same: the FDA does not intend to examine low-risk general wellness products to determine whether they are devices under the Federal Food, Drug and Cosmetic Act (‘FD&C Act’), or, if they are devices, to determine whether they comply with the relevant regulatory requirements. Yarmela Pavlovic, Partner at Hogan Lovells LLP, discusses the Final Guidance and outlines the changes between the final guidance and the draft guidance of February 2015. / read more

While there has been a proliferation of mobile health (‘mHealth’) apps on the marketplace, concerns have grown that users and healthcare organisations are unable to access evidence of the quality and reliability of these apps. Back in February of this year the European Commission began to address this problem by putting together a working group tasked with developing mHealth assessment guidelines, to assist in increasing the safety, quality and reliability of mHealth apps. The second draft of these guidelines was published in May 2016. Marc Martens and Maria-Paz Martens of Bird & Bird, Belgium, discuss the aim and content of the draft assessment guidelines. / read more

Erik Vollebregt, Founding Lawyer at Axon Partners and member of the eHealth Law & Policy Editorial Board, describes the impact of a new classification rule - added unexpectedly at the last minute into the EU Medical Device Regulation - for clinical decision support or monitoring software that is currently a medical device under the Medical Devices Directive. / read more

Since 2014, a major obstacle in digital health in the US has been claiming inventions in a way that is ruled patent-eligible. Here, Antonia L. Sequeira, Partner at Fenwick & West LLP, explains that digital health companies as a group are in a better position for patent eligibility than many other digital/software-based fields, but it is essential to have a customised plan in place for handling eligibility issues before filing a patent application. / 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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