Philippe Bradley-Schmieg’s practice covers a range of commercial, regulatory and intellectual property matters affecting the IT, e-health, internet media and telecoms sectors, often with a multi-jurisdictional scope. He advises on intellectual property, compliance and policy matters such as online consumer rights, liability for third party content, patent, copyright and database right licensing, privacy and data protection, medical confidentiality, cybersecurity, data breach responses, and law enforcement data disclosure. Mr. Bradley-Schmieg advises on UK, EU and international law, and has worked in London and Brussels.
The new EU Medical Devices Regulation (MDR), a draft of which was tentatively agreed by the EU’s legislators on June 15, 2016, was revised at the last minute to include a new classification rule for software. Software’s classification under the MDR will determine its regulatory treatment (including what requirements it has to meet, and what … Continue Reading
In a new post on the Covington eHealth blog, our colleagues provide an analysis of the European Commission’s updated guidance on when medical software will be deemed to be a medical device under EU law. To read the post, please click here.… Continue Reading
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
The UK Information Commissioner’s Office (ICO) has launched an informal survey of current practices relating to the use of data-enabled medical devices and apps. The short and anonymous survey explores whether organisations have put in place specific policies and procedures, asset registers, IT security requirements for medical device procurement policies, information governance and incident response … Continue Reading
On September 18, 2014, the International Medical Device Regulators Forum (IMDRF) approved a potentially significant policy position regarding Software as a Medical Device (SaMD), entitled Software as a Medical Device: Possible Framework for Risk Categorization and Corresponding Considerations (IMDRF/SaMD WG/N12FINAL:2014). The policy was put together by the IMDRF’s SaMD working group, led by an FDA … Continue Reading