Digital Health Legal

Volume: 2 Issue: 6
(June 2015)


The European Data Protection Supervisor (‘EDPS’) Giovanni Buttarelli published on 21 May an Opinion, ‘Mobile health: Reconciling technological innovation with data protection,’ which contains a number of recommendations for mHealth app developers in regards to data protection, and urges developers to be accountable and responsible for privacy, for example by ‘embedding privacy and data protection settings in [app] design.’ / read more

The European Commission (‘EC’) presented plans for an industry-led Code of Conduct for privacy and security in the mHealth sector on 12 May at the eHealth Week Riga 2015 conference; the initiative aims to facilitate compliance by app developers and promote trust. / read more

The US House Energy & Commerce Committee unanimously approved the latest draft of the 21st Century Cures Act (‘21CCA’) on 21 May, which aims to modernise and personalise healthcare in the US. / read more


Bradley Merrill Thompson of Epstein Becker Green provides the US perspective on the pharmaceutical apps available and the regulation of such apps on the US market, which complements Erik Vollebregt’s article from last month’s issue, which focused on the situation in the EU. Bradley and Erik jointly presented on this topic at a DIA meeting in Paris in April. Using a common framework to describe the categories of pharmaceutical apps, Bradley focuses on the Food and Drug Administration’s (‘FDA’) requirements. / read more

How does your city shape your health? How can health services be designed to harmonise with the physical environment? And how can UK organisations maximise the value of multiple datasets relating to personal health in the age of ‘Big Data’? / read more

China is developing as a marketplace for eHealth, but the issues raised by eHealth may not be adequately dealt with by current Chinese regulation. As a result there exist obstacles and ambiguities for private companies looking to offer eHealth products and services into China, as John Balzano, Of Counsel at Covington & Burling, explains. / read more

Next Generation Sequencing (‘NGS’) could have a profound impact on healthcare. Its use leads to the creation of large databases of genomic information of individuals, as well as analysis and interpretation by various stakeholders. Thus it is crucial that the genomic data made available through NGS is adequately safeguarded. Barbara Cammarata, Counsel at Sidley Austin LLP, highlights nuances in US data safeguarding policy that pose challenges for regulators and stakeholders when applied to genomic data. / read more

Ontario’s Personal Health Information Protection Act (‘PHIPA’) was enacted in November 2004 to provide rules and regulations respecting the collection, use, and disclosure of personal health information. Given changes in the technological environment, Jill M. Daley and Karen Sie of Norton Rose Fulbright examine the need to modernise PHIPA in response to technological developments. / read more

Given its reasonably small population and a high incidence of long-term chronic disease, Scotland is an excellent test bed for eHealth. Matthew Godfrey-Faussett and Zara Early of Pinsent Masons LLP set the scene on the development of eHealth in Scotland and the individual initiatives being pioneered. / 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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