European Union

On 28 June 2017, Advocate General Sanchez-Bordona (AG) presented his opinion in case C-329/16 Syndicat national de l’industrie des technologies médicales and Philips France following a request for preliminary ruling from the Conseil d’État (France) to the Court of Justice of the European Union (CJEU) concerning the laws governing the classification of software medical devices.…

Digital health solution providers, and users of digital health services, should take note of three recently launched EU public consultations in the digital health space, and may wish to make submissions to help shape the future of digital health initiatives in the EU.  The earliest deadline for submissions is 16 August 2017.

EU Commission

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The UK Information Commissioner’s Office (“ICO”), which enforces data protection legislation in the UK, has ruled that the NHS Royal Free Foundation Trust (“Royal Free”), which manages a London hospital, failed to comply with the UK Data Protection Act 1998 in providing 1.6 million patient records to Google DeepMind (“DeepMind”), requiring the Royal Free to sign an undertaking committing to changes to ensure it is acting in line with the UK Data Protection Act.

On September 30,  2015, the Royal Free entered into an agreement with Google UK Limited (an affiliate of DeepMind) under which DeepMind would process approximately 1.6 million partial patient records, containing identifiable information on persons who had presented for treatment in the previous five years together with data from the Royal Free’s existing electronic records system.  On November 18, 2015, DeepMind began processing patient records for clinical safety testing of a newly-developed platform to monitor and detect acute kidney injury, formalized into a mobile app called ‘Streams’.
Continue Reading ICO Rules UK Hospital-DeepMind Trial Failed to Comply with UK Data Protection Law

On May 11, 2017, the European Cloud in Health Advisory Council (ECHAC) – a group of healthcare organizations, technology companies and patient representatives  –  launched its second whitepaper focused on use of data to improve health outcomes and delivery of care.

ECHAC launched the whitepaper at an eHealth Week 2017 session attended by ECHAC participants…

The UK Government has opened a consultation, running until September 7, 2016, regarding how UK National Health Service (NHS) patient data should be safeguarded, and how it could be used for purposes other than direct care (e.g. scientific research).

The consultation comes after two parallel-track reviews of information governance and data security arrangements in the NHS found a number of shortcomings, described below.  The  Care Quality Commission (CQC) and the National Data Guardian (NDG, led by Dame Fiona Caldicott) made a range of recommendations, including new security standards, stronger inspection and enforcement around security lapses and re-identification of anonymized patient data, and an eight-point process around assuming and respecting patient consent decisions.

Following the public consultation, the new security standards could eventually be required and audited by government inspectors from the CQC, and imposed under revised standard NHS England contract terms.  CQC inspectors could potentially act on tip-offs from NHS Digital (formerly known as the NHS Health and Social Care Information Centre, ‘HSCIC’).  Those tip-offs could be based on low scores obtained by organizations in their annual NHS Information Governance Toolkit (IGT) self-assessments.  The IGT, which the reviewers said should be redesigned, applies both to NHS bodies and their commercial vendors.

The new consent model, meanwhile, could provide more streamlined, system-wide consents for use of patient data for purposes including quality assurance and research.

The CQC and the NDG’s findings and twenty-four recommendations were jointly presented in a covering letter to the UK government, available here, and fuller reports, available here and here (CQC and NDG, respectively).  This post provides a brief summary of their main findings and recommendations.  For the consultation questions themselves, see here.
Continue Reading UK Government Considering New Patient Data Security and Research Consent Standards, Sanctions

On 15 July 2016, the European Commission updated MEDDEV 2.1/6 (the “MEDDEV Guidance), its medical device guidance on the qualification and classification of stand alone software used in the healthcare setting. The updated version replaces an earlier version of MEDDEV 2.1/6 issued by the European Commission in January 2012.

MEDDEV 2.1/6 generally stands as a valuable resource to assist software developers in the assessment of whether software is a medical device. However, some have expressed disappointment that the updated guidance did not go further in clarifying the picture, particularly those operating within the mobile health (mHealth) space.

Indeed, the main changes consist of additions to the definitions section of the MEDDEV Guidance. There is now a definition to clarify that “software” is a “set of instructions that processes input data and creates output data“. There are also accompanying definitions of “input data” and “output data”.
Continue Reading EU Updates MEDDEV 2.1/6 Guidance on Standalone Software

May 2015 saw a number of developments in the EU mHealth sector worthy of a brief mention.  The European Commission announced that it would work on new guidance for mHealth apps, despite the European Data Protection Supervisor and British Standards Institution publishing their own just weeks earlier.  In parallel, the French data protection authority announced a possible crackdown on mHealth app non-compliance with European data protection legislation.  This post briefly summarizes these developments.
Continue Reading May 2015 EU mHealth Round-Up

Our colleague Monika Kuschewsky recently published a post on the InsidePrivacy blog describing how the Article 29 Data Protection Working Party (Working Party), an independent EU advisory body on data protection and privacy, responded to a request from the European Commission made in the framework of the Commission’s mHealth initiative to clarify the definition of…