Digital Health Legal

Volume: 4 Issue: 7
(July 2017)


The Australian Government announced on 10 July 2017 that it has commissioned a review into the accessibility by health providers of Medicare card numbers, following the recent public discussion about an alleged data breach brought to light on 3 July 2017 by the Guardian Australia, which involved the alleged trading of Medicare card numbers online in exchange for cryptocurrency. According to the media release from Minister for Human Services Alan Tudge and Minister for Health Greg Hunt, the Australian Government wants to ensure that there is increased security in place in a system that is important to both patients and doctors. The Review team will specifically examine the balance between convenience and security to determine its adequacy in today’s context. / read more

The UK’s Care Quality Commission (‘CQC’) published reports on the findings of its recent inspections into the Push Doctor and Pharmacy2U digital services on 22 June 2017 and 29 June 2017 respectively, with both reports raising concerns about the services; the CQC declared that while both online services were providing “caring and responsive services,” neither were providing safe, effective or well-led services. The inspections form part of the CQC’s continuing greater scrutiny of online healthcare services. / read more


At the end of 2017, the Scottish Government is due to issue its Digital Health and Social Care Strategy 2017 - 2022. Matthew Godfrey-Faussett, Partner at Pinsent Masons LLP and Member of the Digital Health Legal Editorial Board, provides an overview of the existing Digital Health Strategy in Scotland and explains why the Scottish Parliament’s current request for input is of importance not just for those interested in the application of digital health within Scotland, but also those working on similar initiatives across the UK and more generally. / read more

Following the publication in February 2017 of National Data Guardian Dame Fiona Caldicott’s letter to the Medical Director at the Royal Free Hospital in London (‘the RFL’), the UK’s Information Commissioner’s Office (‘ICO’) has now concluded her investigation into the ‘Streams’ project, a collaboration between the RFL and Google’s DeepMind business. As part of the development and testing of the Streams application (relating to acute kidney injury), the RFL had transferred some 1.6 million identifiable partial patient records to DeepMind for the purposes of the clinical safety testing of the Streams application, without patient consent. Adam Rose and Nina O’Sullivan of Mishcon de Reya LLP detail the scope of the ICO’s investigation and the outcome, and the lessons to be learned. / read more

Especially in light of recent events, the cyber security threat to healthcare organisations has never been more apparent. In the US, the Health Care Industry Cybersecurity Task Force (the ‘Task Force’) has released its Report on Improving Cybersecurity in the Healthcare Industry (the ‘Report’)1, which assesses the current vulnerabilities in the health sector and considers how to strengthen its defences. Lee Kim, Director, Privacy and Security at HIMSS North America, presents the findings of the Report and provides commentary. / read more

Further utilisation by the UK’s NHS of mobile apps and software is steadily growing; for instance earlier this year the NHS announced a pilot program involving the prescription of an app created by startup OurPath. Given the increased use of such technologies, the legal landscape for the NHS’ use of health and wellbeing apps is increasingly in focus. Hilary Jones and Michaela Herron of Bristows examine this landscape, looking at the regulation of such apps and the liability issues that may arise when they are prescribed on the NHS. / read more

Cyber security issues inherent in the ‘Internet of Things’ (‘IoT’) are a cause for concern including in the healthcare sector. In the US, Federal cyber security policy has been non-regulatory so far. The National Institute of Standards and Technology (‘NIST’) and the National Cybersecurity Center of Excellence (‘NCCoE’) are working at securing the IoT for healthcare; recently for instance NIST and the NCCoE drafted in cooperation with industry a document outlining security practices for wireless infusion pumps used by health delivery organisations. Megan Brown and Sonali Gunawardhana of Wiley Rein LLP discuss the guidance on wireless infusion pumps and whether NIST/NCCoE efforts in the cyber security area will be enough to stave off federal cyber security regulation. / read more

The US Federal Food and Drug Administration (‘FDA’ or ‘Agency’) Commissioner Dr Scott Gottlieb has used an FDA blog post to announce plans for a new digital health devices initiative, specifically the initiative’s Digital Health Innovation Plan, which is intended to provide tools to the Agency that encourage device makers to be innovative and put resources into the development of new digital health devices. Diane Romza-Kutz of Thompson Coburn LLP describes what’s known about the Plan so far. / read more

In the recent presidential election in France on 7 May 2017, Emmanuel Macron was elected for a five year term. During the presidential campaign, Macron claimed that he intends to make healthcare related issues a priority during his tenure. Daniel Kadar and Caroline Gouraud, of Reed Smith LLP, speculate on what the digital health industry can expect over the next five years in France under President Macron. / 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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