On Wednesday 17th September, Health Technology Forum members gathered at Baker Botts’ office in London for a couple of key presentations on legal aspects of medical software.
The first, by Joe Hagan-Brown, Regulatory Affairs Specialist at the MHRA, covered the EU’s medical device-specific regulation. The second, by Alex Denoon of Lawford Davies Denoon, was a presentation on the EU’s data protection regulation.
Readers with long memories will recall that I summarised medical device-specific regulation a while back; much of what Joe said added colour to that summary. A few comments he made are perhaps worthy of repetition (more…)
On Wednesday 17th September the Health Technology Forum in London is meeting again at Baker Botts’ head office at the back of the Bank of England to hear presentations from:
Joe Hagan-Brown, Regulatory Affairs Specialist at the Medicines and Healthcare products Regulatory Agency (MHRA) who has very kindly agreed to present on a huge range of app-related issues including:
The Medical Devices Directive – definition of a medical device; Software- qualification as a medical device; A brief background to software in the context of medical device legislation; Meddev 2.6/1; The market for Apps; MHRA guidance on software as a medical device; Five categories of apps; Classification; Conformity assessment; Telehealth; Vigilance/Post market surveillance; General requirements; Specific considerations
Alex Denoon, from Lawford Davies Denoon who has very indly agreed to talk to us on the impact of the proposed Data Protection Regulation on biomedical research. The talk will cover the (largely unintended) potentially catastrophic effects on matters are diverse as biobanks, personalised medicine, e-health and the development of new medicines.
The plan is to give both speakers plenty of time both for their presentations and to respond to questions, whilst still enabling all present to enjoy Baker Botts’ legendary hospitality for the networking session afterwards.
There are currently 12 spaces left. More details, and how to book are here