Digital Health Legal

Volume: 1 Issue: 5
(June 2014)


The US Federal Trade Commission held a seminar on Consumer Generated and Controlled Health Data (CGHD) on 7 May, to examine the potential risks and benefits of CGHD. The French data protection authority, the CNIL, also held a workshop on connected health and wellness devices on 28 May, during which the CNIL distributed its new publication on ‘the connected body,’ featuring articles on the ‘quantified self,’ including the regulatory challenges posed by the collection of data generated by the human body. / read more

The European Medicines Agency’s (EMA) revised draft policy on ‘Proactive Publication of Clinical-data,’ which was shared with stakeholders in mid-May, imposes greater security measures and confidentiality requirements on accessing trial data. The draft is part of the guidance accompanying the EU Clinical Trials Regulation, which creates a publicly accessible database. / read more

Six UK All Party Parliamentary Groups published on 15 May a joint report on ‘Patient empowerment,’ which aims to encourage NHS England to provide greater interactivity with patient electronic records, as opposed to just allowing access. / read more


Healthcare across the globe is changing and the role of the pharmaceutical company is becoming more important as focus shifts from simply providing just a product to delivering outcomes through more comprehensive solutions. Marco Mohwinckel, Global Head Integrated Care Solutions at Janssen Healthcare Innovation (JHI), a division of Janssen-Cilag Ltd, explains how JHI is accelerating the transformation of Johnson & Johnson from a product-centric company to becoming a provider of broader healthcare. / read more

Between 12 and 18 May 2014 all members of the Global Privacy Enforcement Network (‘GPEN’) - containing 27 privacy enforcement authorities - conducted the 2014 International Privacy Sweep (the ‘Sweep’), focusing on mobile app compliance with data protection laws. The rapid development of the apps sector poses new data protection risks for end users. By Dr. Nadia Arnaboldi Chartered Accountant and Auditor Certified Information Privacy Professional Europe and US (CIPP/E/US). / read more

India’s Ministry of Health and Family Welfare notified the Electronic Health Records Standards for India in August 2013. These Standards are legislated under the Indian Clinical Establishments (Registration and Regulation) Act 2010, meaning that the Standards are applicable only in states that have adopted this legislation. The Standards examine data privacy and security, and in particular stipulate a number of consent requirements needed to obtain a patient’s information, as Prashant Kumar of JSA Law, India, explains. / read more

The new Clinical Trials Regulation will transform the regulation of clinical trials for medicinal products in the EU. In this article, Elisabethann Wright and Ciara Farrell of Hogan Lovells International LLP examine the new Regulation, with a particular focus on a number of the key provisions in the Regulation. / read more

With healthcare information technology, there has been an explosion of applications and devices. But what about the responsible use of technology and ensuring the privacy and security of the information generated by and which flows through such technology? Lee Kim, Director, Privacy & Security, at HIMSS, a global, cause-based, not-for-profit organisation focused on better health through IT, discusses the state of privacy and security of electronic information and how advancements can help us better manage risks in today’s world. / read more

Richard Corbridge, Chief Information Officer & Senior Information Risk Owner at the National Institute for Health Research (NIHR) Clinical Research Network, has led the Knowledge and Information directorate of the NIHR CRN, the research delivery arm of the NHS, since 2011. Richard’s directorate is responsible for providing Information Systems and Business Intelligence to a workforce of around 10,000 staff in the NHS who have been responsible for the recruitment of over 630,000 participants into clinical research in England in 2013. In this article Richard discusses the importance of data analytics for healthcare and what he has learnt through talking to different countries about how they are responding to the challenges. / read more

Tanguy Van Overstraeten, Partner at Linklaters and member of the eHealth Law & Policy editorial board, and Guillaume Couneson, also of Linklaters, Brussels, discuss anonymisation and pseudonymisation in the wake of the Article 29 Working Party’s Opinion 05/2014 on Anonymisation Techniques released on 10 April. / 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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