Digital Health Legal

Volume: 2 Issue: 9
(September 2015)


The UK’s Health Secretary Jeremy Hunt announced on 2 September plans to enable patients in England to access their full GP record online within the next year, including information such as blood test results, and to be able to view online information from all their health and care interactions by 2018. Hunt also expressed his vision that by the next financial year 15% of NHS patients will access NHS records and services on smartphones. / read more

The US FDA announced the launch of a new crowd-sourced, cloud-based platform, precisionFDA, on 5 August, which aims to enable developers of genomic sequencing diagnostics to share data, test methodologies and develop standards. / read more

The European Medicines Agency adopted its ‘EU Telematics Strategy and Implementation Roadmap 2015 - 2017’ on 6 August, which sets out a ‘high-level’ plan for the delivery of IT solutions arising from European pharmaceutical legislation and policy. / read more


Dutch-based cross-border online pharmacy DocMorris was founded 15 years ago, but has faced challenges to operating legally in Germany. However, decisions handed down by the European Court of Justice have helped DocMorris to compete on the German market. Max Müller, Chief Strategy Officer, and Jan Schlimgen, Head of Institutional Relations and Legal Counsel at DocMorris, provide the background to the challenges faced by DocMorris in Germany and the crucial rulings that have enabled the company to flourish across Europe. / read more

In the US, the Office of the National Coordinator for Health Information Technology (‘ONC’) within the Department of Health and Human Services (‘HHS’) has been primarily responsible for defining the parameters of the meaningful use program. Engaging patients and families in their care is a stated objective of the ONC. Robert Jarrin, Senior Director, Government Affairs at Qualcomm Incorporated, explores the history of patient- generated health data as a proposed objective in the meaningful use program and explains why it needs to be part of meaningful use. / read more

A joint governmental data protection criminal task force (the ‘Task Force’), which was launched in April 2014 to strengthen personal information security through integrated investigations into personal data breaches, recently indicted IMS Health Korea, the Korean branch of a multinational medical information processing company, among others, for a medical data breach in violation of the Personal Information Protection Act (‘PIPA’). / read more

The US Food and Drug Administration (‘FDA’) first issued a Safety Communication on the threat posed by cyber security vulnerabilities in medical devices back in June 2013. That Communication provided information on the kind of cyber security issues being seen and suggested preventative actions for healthcare facilities. In July this year the FDA released another such Safety Communication, this time focused on cyber security vulnerabilities relating to Hospira’s Symbiq Infusion System. Sonali P. Gunawardhana, Of Counsel at Wiley Rein, outlines the contents of the Safety Communications released by the FDA thus far and how the FDA suggests healthcare facilities should mitigate cyber security risks. / read more

A study by mobile research specialists research2guidance in partnership with HIMSS Europe has identified Denmark as the best EU Member State in which to start a mobile health (‘mHealth’) business. In this article Hans Erik Henriksen, CEO of Healthcare DENMARK, explains the reasons why he thinks Denmark has achieved such a status in Europe. / read more

On 24 July 2015 the Belgian government adopted its strategy for Open Data (‘ODS’). More specifically, the Council of Ministers approved the proposed federal ODS as well as draft legislation relating to the use of public sector information (‘PSI’). The new legislation will transpose into Belgian law the EU Directive on the re-use of public sector information (Directive 2003/98/EC, revised by Directive 2013/37/EU, also known as the ‘PSI Directive’). The PSI Directive focuses on economic aspects in connection with the re-use of public sector information. It addresses data that public sector bodies in EU Member States collect and store at national, regional and local levels. With the adoption of its ODS, the Belgian government has taken another step towards the strengthening of the country’s digital ecosystem and the simplification of public administration. / read more

Preparing for data breaches - and the aftermath - is a crucial matter for healthcare providers. Lynn Sessions, Partner at BakerHostetler has handled over 300 healthcare data breaches, and here provides her take on data breach prevention, protection and preparedness. / read more

Part of an EU-funded programme, GET Funded targeted European digital health SMEs looking for follow-up investments - typically between €0.5 million and €2 million - and was designed to provide them with training, resources and networking opportunities. In two years, we worked with 50 start-ups, trained them and placed over 30 of them on stage to pitch in front of investors. So, what did we learn? / 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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