Following a report carried out by French economist and public policy expert Jean Pisani-Ferry, the French Government presented on 25 September 2017 the outline of its investment strategy for 2018-2022. Of the €57 billion budget announced by the Government, €4.9 billion is intended to be spent on the digital transformation of the French health system and for the creation of a digital health ecosystem in France. Christophe Fichet, Benjamin Znaty and Edwige Lataste of Simmons & Simmons discuss the proposals put forward in the Pisani-Ferry report, which provide valuable insight into what the digital health roadmap in France might look like for the years ahead. / 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

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 Health Secretary announced on 7 September 2016 a number of digital technology measures for use by NHS patients, including the launch of a library of NHS-assessed apps, following a report published the same day by the National Advisory Group on Health IT in England, chaired by Professor Wachter (‘Report’). / read more

The UK Health Secretary Jeremy Hunt announced on 7 September 2016 at the Health and Care Expo in Manchester a number of digital technology measures for use by NHS patients, including the launch of a library of NHS-assessed apps by NHS England; the announcement follows a report, ‘Making IT work: harnessing the power of health information technology to improve care in England,’ (‘Report’) published on 7 September 2016 by the National Advisory Group on Health Information Technology in England, chaired by Professor Robert Wachter. / read more

Following the publication of Dame Fiona Caldicott’s long-awaited review of data security, consent and opt-outs relating to how patient data is being used within the NHS, Matthew Godfrey-Faussett, Partner at Pinsent Masons LLP and member of the eHealth Law & Policy editorial board, and Paul Greaves, also of Pinsent Masons LLP, consider the recommendations and wider implications of what is the third report (‘Caldicott3’) to be published by Dame Fiona Caldicott in her capacity as National Data Guardian (‘NDG’). / read more

Following the publication of the agreed texts of Europe’s Medical Devices Regulation (‘MDR’) and the In Vitro Diagnostic Medical Devices Regulation (‘IVDR’) on 15 June 2016, Dr Lincoln Tsang, Partner at Arnold & Porter LLP and Erik Vollebregt, Founding Lawyer at Axon Lawyers, provide their immediate reactions to the texts of both Regulations and the provisions that have been included that will directly impact Europe’s eHealth market. / read more

The first extraction will take place from GPs in December of opt-out requests from patients who opted-out of the care.data initiative or from their data being shared with third parties by the UK’s Health and Social Care Information Centre (‘HSCIC’), following the Government leaflet campaign about the care.data initiative in January 2014. According to HSCIC, all objections are set to be implemented in January 2016. / read more

The French Council of State (‘Conseil d’Etat’) annulled, on 24 February, some of the provisions of the French Sunshine Act, which imposes disclosure obligations on healthcare companies, following legal action by the French Medical Board and a non-profit organisation against the law’s implementing decree and its explanatory circular. / read more

A decree to implement electronic health records (‘EHRs’) in Italy is currently in draft form, following the passing of a law in 2012 establishing the rules and principles necessary for implementing EHRs. The Italian Data Protection Authority, the Garante, has issued a favourable verdict on the draft but has argued for some amendments, as Laura Liguori of Portolano Cavallo Studio Legale explains. / read more