Digital Health Legal

Volume: 4 Issue: 10
(October 2017)


On 27 September 2017, the Creating High-Quality Results and Outcomes Necessary to Improve Chronic Care Act of 2017 (‘Chronic Care Act’) was unanimously passed by the US Senate, and if signed into law would introduce a provision for optional telehealth appointments to be provided as part of Medicare Advantage Plan benefits. This was followed by the publication of a ‘proposed rule,’ on 2 October 2017, by the Department of Veteran’s Affairs (the ‘VA’) which, if approved, would permit telehealth services to be provided to veterans regardless of the state in which they are located. Both proposed regulations “present tremendous potential to increase access to telehealth services for two substantial and vulnerable populations,” comments Amy Lerman, Member at Epstein Becker Green. / read more

The European Commission proposed on 19 September 2017 a regulation on the free flow of non-personal data in the EU, with the intention of contributing to a ‘more competitive and integrated EU market for data storage and data processing services,’ by addressing concerns around data localisation and removing obstacles to cross-border data flows; the proposed Regulation will exclude data concerning health on the grounds that it is personal data under the EU General Data Protection Regulation (‘GDPR’), but will apply to anonymised health data, being non-personal data. / read more


Online doctor services have come under increased scrutiny from the media and regulators over the past 12 months, resulting in significant changes to the regulatory landscape. Raj Gathani and Brian Kelly of Covington & Burling LLP examine the developments taking place in this sector of the telehealth industry and in particular the standards that apply to online doctor providers in the UK. / read more

As Australia seeks to take steps towards a uniform, digitised approach to health data records and patient access as part of its National Digital Health Strategy (2018-2022) (the ‘Strategy’), recent incidents such as when Medicare card details of Australian citizens were stolen and sold on the dark web, illustrate the potential risks that come with moving health records online and with the Strategy. Toby Patten and Rowena Baer, of Baker McKenzie, provide their assessment of the Strategy and consider what the future could look like for digital health uptake in Australia. / read more

Sir John Bell’s Report to the UK Government on the Life Sciences Industrial Strategy1 (the ‘Strategy’) was published on 30 August 2017 in response to the life sciences sector being identified as one of the UK’s five leading sectors in the Government’s ‘Building our Industrial Strategy: green paper.’ In this article, Hilary Jones, Of Counsel at Bristows, considers the Strategy’s vision for the role of digital technology in improving health outcomes, the life sciences sector and the UK economy. / read more

The Milan Civil Court issued on 24 July 2017 a judgment on whether the publication by pharmaceutical company DOC Generici S.r.l. (‘DOC Generici’) of a list of its medicinal products and the pricing information on its website and in print journals should be qualified as advertising, and therefore fall under the Italian legislation on the advertising of medicinal products. In reaching its conclusion the Court drew on criteria established in a 2011 ruling by the Court of Justice of the European Union, in MSD Sharp & Dohme GmbH v. Merckle GmbH. Elisa Stefanini of Portolano Cavallo analyses the Milan Civil Court’s ruling, which represents one of the few judgments by Italian civil courts to consider the advertising of medicinal products. / read more

On 29 July 2017, the Russian State Duma approved Federal Law No.242-FZ ‘On Amending Certain Legal Acts of the Russian Federation on the Use of Information Technologies in the Area of Health Care,’ (the ‘Law on Telemedicine’) set to take effect from 1 January 2018. This milestone piece of legislation has been issued in response to the growing uptake of telemedicine services in Russia, and here Julianna Tabastajewa and Meldir Erbulekova, of Gowling WLG, provide their take on the new Law and the likely impact it will have on Russian healthcare. / read more

The EU has since 2014 run a European Health Parliament (‘EHP’) to explore solutions to Europe’s healthcare problems. As part of this, the topic of ‘big data in healthcare’ has been discussed, with one EHP proposal being the creation of a Europe-wide connected Electronic Health Records Organisation (‘EHRO’), with the intention being to collect and use patients’ health data across Member States and thus empower patients and enable better health outcomes. Zeger Vercouteren, Vice President Government Affairs & Policy EMEA at Johnson&Johnson - the founding partner company of the EHP - outlines the aims and interests of the EHP, before looking in detail at the proposal for an EHRO and why it’s needed. / 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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