Digital Health Legal

Volume: 3 Issue: 8
(August 2016)


The US HHS Office for Civil Rights (‘OCR’) released on 11 July 2016 new Health Insurance Portability and Accountability Act (‘HIPAA’) guidance relating to ransomware, in the light of a reported increase in such attacks, including on hospitals. / read more

The Office of the National Coordinator for Health Information Technology (‘ONC’) released on 19 July 2016 its report to the US Congress, ‘Examining Oversight of the Privacy & Security of Health Data Collected by Entities Not Regulated by HIPAA’ (‘Report’), which details the possible risk to protected health information (‘PHI’) resulting from entities not covered by the Health Insurance Portability and Accountability Act 1996 (‘HIPAA’). / read more

The European Commission has proposed closer convergence with the US on the regulation of medical devices, in a proposal for an annex on medical devices made public on 14 July 2016, as part of the ongoing negotiations of the Transatlantic Trade Investment Partnership (‘TTIP’) between the US and EU. / read more

The EU Commission issued an updated version of the MEDDEV 2.1/6 guidance document on the qualification and classification of standalone software used in healthcare within the regulatory framework for medical devices on 15 July 2016. The new version of the MEDDEV explicitly states that the criteria set out in the guidance document also apply to mobile applications. / read more

The US Food and Drug Administration’s (‘FDA’) Center for Devices and Radiological Health (‘CDRH’) released on 29 July 2016 its finalised enforcement discretion policy guidance on low risk general wellness devices (‘Guidance’), which confirms that the FDA has no intention of actively regulating such products. The Guidance, which is intended to indicate the FDA’s thinking in this area and is to be viewed only as recommendations, retains the approach adopted in the FDA’s draft of the guidance, published on 20 February 2015. / read more

The European Medicines Agency (‘EMA’) released guidance on good manufacturing practice (‘GMP’) to ensure the integrity of data on 11 August 2016, which was accompanied by the issuance of draft guidance by the Pharmaceutical Inspection Co-operation Scheme (‘PIC/S’) on 10 August 2016 on good practices for data management and integrity in regulated GMP and good distribution practice (‘GDP’) environments; both documents aim to ensure data integrity during the testing, manufacturing, packaging, distribution and monitoring of medicines. / 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 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


Following the publication of Dame Fiona Caldicott’s long-awaited review of data security, consent and opt-outs relating to how patient data is being used within the NHS, Matthew Godfrey-Faussett, Partner at Pinsent Masons LLP and member of the eHealth Law & Policy editorial board, and Paul Greaves, also of Pinsent Masons LLP, consider the recommendations and wider implications of what is the third report (‘Caldicott3’) to be published by Dame Fiona Caldicott in her capacity as National Data Guardian (‘NDG’). / read more

Additive manufacturing (‘AM’) - 3D printing - is particularly appealing in the medical device field, where it can be used to create anatomically-matched devices by using a patient’s own medical imaging. In May 2016 the US Food and Drug Administration (‘FDA’ or ‘Agency’) issued preliminary guidance for device manufacturers using AM. Jordan T. Cohen of Mintz Levin provides an overview. / read more

The barriers to the widespread adoption of telemedicine are many, but providers and regulators are working to remove the roadblocks. Hannah Willson and Marcus Vass of Osborne Clarke LLP discuss the legal issues surrounding telemedicine in Europe and the progress made in addressing them. / read more

At the end of the month of May 2016 the Portuguese Data Protection Authority (‘CNPD’) made available a specific new online notification form for clinical research purposes. / read more

Breaches of medical records and incidents of ransomware attacks at healthcare organisations have become an unfortunate trend in the US healthcare industry. Joan Antokol, Founder of Park Legal LLC, looks at the circumstances behind this trend and provides security recommendations to help abate the problem. / read more

The e-pharmacy sector has become firmly established in India, but with India lacking legislation to specifically cover the sale of drugs via the internet, there is regulatory ambiguity as to some activities within the Indian e-pharmacy sector, such as whether a website that does not sell drugs but merely connects customers with retailers is covered by India’s laws on the sale and distribution of drugs. Nirupam Lodha and Rhyea Malik of Luthra & Luthra Law Offices discuss the regulatory challenges facing India’s e-pharmacies. / 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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