Digital Health Legal

Volume: 2 Issue: 1
(January 2015)


The European Commission published its Summary Report on the public consultation on the Green Paper on mobile health (‘mHealth’) on 12 January, which provides an overview of the responses from stakeholders to issues related to the uptake of mHealth in Europe. / read more

The EU Council of Ministers latest draft of the General Data Protection Regulation dated 19 December contains proposals significant for healthcare, which include an emphasis on enabling health data exchanges and the introduction of a definition of pseudonymous data. / read more

The US Food and Drug Administration (FDA) proposed a rule on 18 December requiring pharmaceutical firms to electronically distribute prescribing information (PI) for drugs intended for healthcare providers, where the PI appears on or inside the package from where the product is dispensed. Manufacturers would send PI updates to the FDA to post to its website. / read more


Despite months of discussion, the EU Council has yet to reach an agreement on the proposed Medical Devices Regulation. Geneviève Michaux and Nicolas Herbatschek of Hunton & Williams, analyse the recent progress report published on 25 November 2014, which sheds light on the Council’s current position. / read more

Discussions on the draft EU General Data Protection Regulation (‘GDPR’) are of certain interest to those involved in the collection, processing and storage of health data. The latest draft, dated 19 December 2014 and reflecting discussions of the EU Council, allows us to analyse the direction in which the Regulation is going and provides insight into how the Regulation might impact the future use of health data, as Victoria Hordern, of Hogan Lovells, explains. / read more

As of 1 July 2014, Canada has one of the most strict anti-spam regimes in the world. Canada’s Anti-Spam Legislation or ‘CASL’ regulates the manner in which email and other electronic messages may be sent into Canada - regardless of where the sender originates. Michael Watts, Partner and Chair of the Health Industry Group at Osler analyses CASL as applied to the pharmaceuticals and healthcare industries and provides a list of key components for compliance. / read more

Towards the end of 2014, the UK’s Health and Social Care Information Centre (‘HSCIC’) issued its summary update (the ‘Update’) on the progress of recommendations made in its ‘Review of data releases Report by the NHS Information Centre,’ published in June 2014 (the ‘Review’). The Review’s focus was on the role of the NHS Information Centre, HSCIC’s predecessor, in the collection and management of health data and the data sharing arrangements put in place with third parties to determine and restrict the use of those data. Valerie Surgenor and Craig Houston of MacRoberts LLP discuss the detail of the HSCIC’s Update. / read more

Mobile health (‘mHealth’) has become one of the hottest trends within the medical industry, offering accessible healthcare by facilitating self-diagnosis and self-treatment of medical conditions via mobile apps. Implemented effectively mHealth will cause a shift from the traditional ‘teacher-pupil’ model (where patients rely on doctors for diagnosis) to one where the patient self-educates under the ‘supervision’ of the doctor. In doing so the patient has to consent to the risks of treatment and make potentially life changing choices independently, becoming increasingly responsible and culpable for his/her health. But are consumers really to blame if they put their trust in an unregulated app that on the surface appears medically valid? / read more

Finland is currently in the process of transferring to nationwide data system services for the healthcare and social services sectors, which will consist of the creation and use of an electronic prescription system, a patient documentation archive and an associated medicine database, as well as access to prescription and patient data and patients’ data management services. These services are referred to together as the ‘Kanta’ services, and are based on the Act on Electronic Processing of Social and Health Care Customer Data (158/2007, ‘Customer Data Act’) and the Act on Electronic Prescriptions (61/2007), which entered into force in 2007. Jan Lindberg and Kiira Lehtonen of Helsinki based Attorneys at Law Trust Ltd outline the requirements for joining the Kanta services as well as the challenges facing the use of data systems for healthcare in Finland. / read more

On 28 October 2014, the Australian Government tabled the Information Commissioner’s Annual Report of its eHealth activities for the Australian financial year 2013-14 (the ‘Report’)1. The primary purpose of the Report is to provide an overview of the Office of the Australian Information Commissioner’s (‘OAIC’) eHealth compliance and enforcement activities. An important aspect of the OAIC’s work is reviewing implementation of the electronic health records initiative. However, the Report also provides information about the OAIC’s other eHealth-related activities. These include audits and assessments conducted in the eHealth sector under the Privacy Act 1988 (Cth) (‘Privacy Act’), provision of privacy advice and consultations with key stakeholders, including the PCEHR System Operator (currently, the Secretary for the federal Department of Health). The OAIC is required to prepare and submit its Report under the Personally Controlled Electronic Health Records Act 2012 (Cth) (‘PCEHR Act’) and the Healthcare Identifiers Act 2010 (Cth) (‘HI Act’). This article provides a short summary and analysis of the Report. / read more

In October 2014 NHS England published its Five Year Forward View. This document is of particular interest to those involved in the interaction between health, technology and information, and is designed to set out the direction for the NHS over the next five years. In particular it describes how the NHS will change, with technology and information underpinning activities across many areas. In this article, Dean Arnold, UK Health Industries Leader, and Mike Farrar, Member of the Health Industries Oversight Board, at PwC discuss the Five Year Forward View, its pledge to ‘exploit the information revolution,’ and why there are reasons to be optimistic about the NHS’ plans. / 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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