Digital Health Legal

Volume: 3 Issue: 2
(February 2016)


The US Food and Drug Administration (‘FDA’) released draft guidance on ‘Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices’ on 26 January for public comment, which aims to clarify how the FDA evaluates devices that connect to and interact with other devices or systems. The draft guidance provides direction on the design and testing of interoperable devices and detailed recommendations on the information that should be provided on the labelling for connected devices. / read more

The European Commission (‘EC’) announced on 15 January that it has set up a Working Group charged with the development of guidelines aimed at determining the reliability and validity of the data mobile health (‘mHealth’) apps collect and process. / read more

Vulnerabilities concerning the integrity of fitness data could call into question real-world uses of such data, a study published on 2 February by Open Effect and the University of Toronto has found. / read more


With the encouragement of the European Commission, an industry Code of Conduct is under construction to help ensure user privacy in regard to mobile health (‘mHealth’) apps. A draft version of this Code of Conduct was presented in December 2015, and while not complete the draft indicates the areas of priority for those tasked with drafting the Code, such as transparency and effective security. Hans Graux, Partner at Time.lex law firm and the Editor of the Code of Conduct, explains the need for such a Code and outlines the draft presented at the end of last year. / read more

In January the US Food and Drug Administration (‘FDA’) published draft guidance, ‘Postmarket Management of Cybersecurity in Medical Devices; Draft Guidance for Industry and Food and Drug Administration Staff.’ This draft guidance aims to clarify the FDA’s postmarket recommendations associated with mitigating cyber security threats to device functionality and device users and to encourage manufacturers to implement an effective cyber security risk management programme throughout the lifecycle of a medical device. Lee Kim, Director of Privacy and Security at HIMSS North America, discusses the draft guidance. / read more

Ian Gallifant, Founder and CEO of mobile and online health platform Medelinked, argues in this article that there is an increasing need for patients to take responsibility for managing their own health as part of the overall modernisation needed in healthcare systems. For this to happen, patients need to be engaged, and devices such as smartphones can be important tools in achieving this. Ian details what in his view is wrong with current healthcare systems, and the importance of placing engaged patients at the centre of care systems. / read more

The IEEE Standards Association (‘IEEE-SA’) published in September the IEEE-SA 2410™-2015 ‘Biometrics Open Protocol Standard (‘BOPS’), a set of standards around the use of secure biometrics. Scott Streit, Chair of the IEEE-SA BOPS Working Group, explains the story behind BOPS’ development and how it illustrates numerous key drivers behind eHealth standards in general. / read more

The US is often criticised for having insufficient data privacy laws and enforcement practices. Joan Antokol, Partner at Park Legal LLC, puts this criticism under the spotlight in relation to enforcement of the Health Insurance Portability and Accountability Act (‘HIPAA’)-Health Information Technology for Economic and Clinical Health (‘HITECH’) Act Rules, and the perceptions that, from a healthcare industry perspective, it appears as though major HIPAA-HITECH settlements with US healthcare organisations are announced on a regular basis. / read more

Each year, the Personal Connected Health Alliance (‘PCHA’) publishes the Continua Design Guidelines (‘CDGs’), which define an implementation framework for end-to-end interoperability from sensors to health services. These guidelines have been adopted in Denmark and Norway for use in their health IT frameworks. Rob Havasy, Vice President of the PCHA, outlines the scope and approach of the CDGs, their high-level architecture and underlying standards. / 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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