Digital Health Legal

Volume: 2 Issue: 5
(May 2015)


The British Standards Institution (BSI) published on 30 April a new code of practice for healthcare app development, which aims to provide a set of principles for developers in order to build trust amongst healthcare professionals, patients and the public in their products and services. / read more

The French National Assembly adopted draft legislation on 14 April, which would create a national health database in France. According to the proposals, health data from multiple sources would be aggregated in a National System of Health Information (SNDS). / read more

The Texas Medical Board voted on 10 April to introduce a new rule on the practice of telemedicine in the state, which would mean that a doctor-patient relationship, necessary under state law for treatment to be given, cannot be established by ‘questions and answers exchanged through email, electronic text, or chat or telephonic evaluation of or consultation with a patient.’ / read more


Erik Vollebregt, Partner at Axon Lawyers, discusses the research carried out into the success of apps developed by pharmaceutical companies, and provides detailed analysis of the pharmaceutical apps available on the market and how each type of app fits into the EU regulatory requirements depending on its specific functionality. / read more

While US healthcare reform emphasises information sharing, health systems and their vendors must comply with laws such as the Health Insurance Portability and Accountability Act 1996 (‘HIPAA’); as a result full access to data may be blocked in the interest of security, for instance. The Office of the National Coordinator for Health Information Technology (‘ONC’) published a report in April, in response to a request from Congress, on the extent of Health Information Blocking and a strategy to address it, as Sheryl Tatar Dacso and John Tomaszewski of Seyfarth Shaw LLP discuss. / read more

A draft law has been put forward in Portugal to amend the country’s Law-Decree 102/2007 of 2 April, which implemented the EU Good Clinical Practice Directive in Portugal. The proposed law would allow auditors and inspectors direct access to original medical records in order to verify clinical trial procedures and/or data in accordance with the Directive. Mónica Oliveira Costa of Coelho Ribeiro & Associados analyses the draft law and the criticisms it faces. / read more

Charlotte Davies, Lead Analyst in the Healthcare and Life Sciences team at Ovum, reports on the HIMSS 2015 conference held in mid-April in Chicago. Charlotte discusses some of the good and promising - as well as the less positive - developments that emerged from the event. / read more

Maintaining the security of protected health information (‘PHI’) is far from an easy task for companies, as they are often forced to balance the need to protect information whilst striving to utilise innovations such as big data. Rick Hindmand of McDonald Hopkins LLC details the challenges facing organisations in protecting health information and rules surrounding encryption. / read more

The Turkish Ministry of Health (‘MoH’) has begun its ‘E-Pulse Project,’ a government initiative that allows access by the public to their own health data online; users will then be able to manage their data using the Project’s online portal, and request the deletion of data if they wish. As is common with initiatives of this nature, the Project has raised data privacy and security concerns, and even prompted a lawsuit from the Turkish Medical Association. Selin Sinem Erciyas and Tuğçe Avcısert Geçgil of Gün + Partners discuss the aims and workings of the E-Pulse Project and the concerns. / 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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