Digital Health Legal

Volume: 2 Issue: 7
(July 2015)


The European Commission (‘EC’), European Parliament (‘EP’) and EU Council began on 24 June trilogue discussions on the draft General Data Protection Regulation (‘GDPR’), following the agreement of a general approach text (‘GA’) by Ministers from the Justice and Home Affairs Council of the EU on 15 June. / read more

The European Commission’s rules relating to the common logo for selling medicines online in Europe, introduced by the Falsified Medicines Directive in order to combat an increase in falsified medicinal products entering the EU, came into force on 1 July. / read more

Germany’s draft eHealth bill received its first reading in the German Parliament on 3 July. The first reading of the much-debated bill has shown there is broad consensus that the bill is a first step in the right direction for further developing the infrastructure and parameters for eHealth solutions in Germany, thinks Dr Roland Wiring, Counsel at CMS Hasche Sigle. / read more


On 6 May the European Commission (‘EC’) published its Digital Single Market Strategy, which aims to, inter alia, maximise the digital economy’s potential for growth via 16 initiatives to be delivered by the end of 2016. Some of these initiatives, for example those that look at interoperability, have a particular bearing on the eHealth sector, as Christophe Fichet and Andrew McMillan of Simmons & Simmons explain. / read more

Caroline Rivett of KPMG discusses how cloud technology can support digital health, and provides guidance on how the decision, the move, and its management must be properly thought through to protect the sensitive medical information that is so highly valued on the dark web. / read more

On 28 May, the Italian National Bioethics Committee (‘NBC’) published a paper entitled ‘Mobile Health Apps: bio-ethical aspects.’ The paper presents a survey of several bioethics problems involving mobile health (‘mHealth’) and identifies possible solutions, as Silvia Stefanelli of Stefanelli & Stefanelli Law Firm explains. / read more

The data handled by healthcare providers and their related vendors in the US comprises of a number of components. Recognising the importance of each of these, Kenneth K. Dort, Partner at Drinker Biddle, focuses in this article on the two components most important to patients: the security of their medical and financial data. / read more

In Ireland the process of prescribing medication, particularly in a community setting, has remained largely untouched by developments in information communication technology over the last 30 years. This is perhaps most surprising when the potential benefits of moving to a computerised prescription model have been well understood since at least the turn of the century1. Addressing this gap through the development of ePrescribing is a key priority of Ireland’s National eHealth Strategy (2013)2. For this purpose the Health Information and Quality Authority (‘HIQA’) has published two new standards for ePrescribing and the electronic transfer of prescriptions. / read more

The United States District Court of the Western District of Texas blocked the Texas Medical Board from enforcing a new rule relating to the practice of telemedicine, in a ruling made in May following a lawsuit brought by telemedicine provider Teladoc, Inc. The rule in question would have prevented physicians from using the telephone as a means to diagnose and treat Texas patients without the patient first being seen either in person or via certain methods of video engagement. Teladoc claims that such a rule is anti-competitive, and that it would destroy their business. The Texas Medical Board has now filed for the Court to dismiss Teladoc’s lawsuit. Julian Rivera, Partner at Husch Blackwell LLP discusses the many twists and turns in the dispute between Teladoc and the Texas Medical Board so far, as well as the arguments put forward by both parties and the implications of the Court’s upcoming decision. / 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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