On 11 November 2020, the European Data Protection Board (“EDPB”) issued two draft recommendations relating to the rules on how organizations may lawfully transfer personal data from the EU to countries outside the EU (“third countries”). These draft recommendations, which are non-final and open for public consultation until 30 November 2020, follow the EU Court … Continue Reading
Public-health researchers, officials and medical professionals rely on data to track outbreaks, advance research, and evaluate prospective treatments. One critical source of patient data comes from electronic health records (EHRs). EHR data in the U.S. has traditionally been siloed within hospital IT systems, but the federal government and key healthcare stakeholders have recently ramped up … Continue Reading
On 13 August 2019, the European Commission opened a call for expression of interest to relaunch the eHealth Stakeholder Group with a view to supporting the “digital transformation of healthcare in the EU”. The eHealth Stakeholder Group was first launched in 2012 and in its first iteration (between 2012 and 2015), contributed to the development … Continue Reading
On 6 December 2018, the European Economic and Social Committee (EESC) published an opinion (“Opinion”) addressing the European Commission’s recent Communication on the digital transformation of health and care in the Digital Single Market (issued 25 April 2018). The EESC is an advisory body of the European Union (“EU”) comprising representatives of workers’ and employers’ … Continue Reading
On 17 October, the UK Government’s Department of Health and Social Care (DHSC) published a policy paper entitled “The future of healthcare: our vision for digital, data and technology in health and care” (the Policy Paper). The Policy Paper outlines the DHSC’s vision to use technology across the health and care system, from “getting the … Continue Reading
On 8 October, the European Medicines Agency (EMA) published a report (available here) setting out the progress it has made towards applying a common data model (CDM) in Europe. The EMA defines a CDM as “a mechanism by which raw data are standardized to a common structure, format and terminology independently from any particular study … Continue Reading
Designing data-driven products and services in compliance with privacy requirements can be a challenging process. Technological innovation enables novel uses of personal data, and companies designing new data-driven products must navigate new, untested, and sometimes unclear requirements of privacy laws, including the General Data Protection Regulation (GDPR). These challenges are often particularly acute for companies … Continue Reading
On 5 September, in response to the opportunities presented by data-driven innovations, apps, clinician decision support tools, electronic health care records and advances in technology such as artificial intelligence, the UK Government published a draft “Initial code of conduct for data-driven health and care technology” (Code) for consultation. The Code is designed to be supplementary … Continue Reading
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 Transformation … Continue Reading
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 … Continue Reading
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 and … Continue Reading
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 … Continue Reading
Earlier today, on the InsidePrivacy blog, our colleagues Mark Young and Phil Bradley-Schmieg posted a summary of the UK government’s announcement of a new national service providing expert cybersecurity advice to entities within the National Health Service (NHS) and the UK’s broader healthcare system. The project, called CareCERT (Care Computing Emergency Response Team), is aiming for a … Continue Reading
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 … Continue Reading
