Digital Health Legal

Volume: 3 Issue: 11
(November 2016)


The Court of Justice of the European Union (‘CJEU’) issued a landmark ruling in case C-148/15 Deutsche Parkinson Vereinigung eV v. Zentrale zur Bekämpfung unlauteren Wettbewerbs eV on 19 October 2016 concerning the cross-border sale of prescription medicines online. / read more

The European Commission launched a public consultation on strengthening cooperation on Health Technology Assessments (‘HTAs’) across EU Member States on 21 October 2016, which aims to gather stakeholder views on the approach proposed in the Inception Impact Assessment. The Commission’s consultation is part of the broader ongoing challenge facing healthcare globally concerning access to new medical technologies and medicines, set against the need to control healthcare costs. / read more


EU Regulation No. 910/2014 on ‘Electronic Identification and Trust Services for Electronic transactions in the European internal market’ (‘eIDAS’) came into force on 1 July 2016. Given the cross-border digital interactions involved, there are numerous implications for eHealth. Rocco Panetta and Federico Sartore of NCTM Law Firm analyse the eIDAS Regulation in the context of eHealth. / read more

The United States Food and Drug Administration (‘FDA’ or ‘Agency’) issued in August 2016 two pieces of guidance that are aimed at assisting medical device manufacturers in determining whether a proposed change to a device cleared under Section 510(k) of the Food, Drug and Cosmetic Act means that the device manufacturer must make a new submission to the FDA. The pieces of guidance issued respectively cover general changes, such as to labelling, and changes to software specifically. Yarmela Pavlovic, Danielle C. Humphrey and Kristin Zielinski Duggan of Hogan Lovells discuss how these two new guidance documents help manufacturers with this tricky aspect of regulatory compliance and provide additional detail to be used in assessing changes to previously cleared products. / read more

Information from the UK Information Commissioner’s Office (‘ICO’) indicates that healthcare sector data breaches have accounted for almost half of all data breaches reported to the ICO within each of the last quarter of 2015/16 and the first quarter of 2016/17. Given the mandatory reporting requirements that apply to healthcare organisations in England however, this may not be overly surprising. Val Surgenor and Amy Drew of MacRoberts LLP analyse the ICO’s report and why healthcare sector breaches might make up such a high percentage of total breaches reported, and then examine how organisations might learn from incidents, and the role of data protection audits. / read more

On 4 August 2016 Advocate Health Care Network (‘Advocate’) agreed with the US Office of Civil Rights (‘OCR’) a $5.55 million settlement following enforcement by the OCR of the Health Insurance Portability and Accountability Act 1996 (‘HIPAA’) - a record settlement penalty. Advocate agreed as part of the settlement to a corrective action plan (‘CAP’), perhaps the most comprehensive in OCR settlement history. Kelly T. Hagan of Schwabe, Williamson & Wyatt analyse the settlement and the plan, and how they fit into trends around HIPAA enforcement. / read more

Law No. 2016-41, of 26 January 2016, which is aimed at modernising France’s health system and is known as the Touraine Law after the Health Minister who introduced it, has instigated a far-reaching reform of the French Public Health Code, and touches on a number of issues relating to eHealth. Pierre Desmarais of Desmarais Avocats describes the provisions of the law and its impact on areas such as electronic health records and security. / read more

A number of initiatives and developments signify that the Indian Government is keen to be involved in pushing the health sector towards going ‘digital’; for instance the National Pharmaceutical Pricing Authority (‘NPPA’) has released the Pharma Sahi Daam app, which assists the public in accessing information about drug pricing in India. Darren Punnen, Anay Shukla and Dr Milind Antani of Nishith Desai Associates describe how Indian patients, industry and regulators are embracing digital. / 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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