Tag Archives: consultation

NMPA Releases Draft Good Manufacturing Practice Appendix on Standalone Software

On January 3, 2019, the National Medical Products Administration (“NMPA”) published a draft standalone software appendix of medical device good manufacturing practice (“Draft Standalone Software GMP” or “Draft Appendix”) for public comment (available here).  Comments are due on January 30, 2019. China revised its medical device GMP in 2014, which apply to all classes of … Continue Reading

IoT Update: The UK Government’s Response to Centre for Data Ethics and Innovation Consultation

On 20 November 2018, the UK government published its response (the “Response”) to the June 2018 consultation (the “Consultation”) regarding the proposed new Centre for Data Ethics and Innovation (“DEI”). First announced in the UK Chancellor’s Autumn 2017 Budget, the DEI will identify measures needed to strengthen the way data and AI are used and … Continue Reading

Europe Consults on Digital Health

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

UK Government Considering New Patient Data Security and Research Consent Standards, Sanctions

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

Summary Report of European Commission’s mHealth Consultation Published

The European Commission has finally published its summary of 211 responses to its mobile health (“mHealth”) consultation.  The summary and original responses to the consultation have been made available on the Commission’s website at https://ec.europa.eu/digital-agenda/en/news/summary-report-public-consultation-green-paper-mobile-health The consultation covered a broad range of important issues for mHealth, including legal frameworks, privacy and data protection, patient safety, … Continue Reading
LexBlog