Medical Device Hackers Now Deemed Allies By FDA, Industry
This article was originally published in The Gray Sheet
Executive Summary
FDA and industry has changed their approach to hackers, and the hacking community has taken notice. As medical devices increasingly become connected, hackers want to be a part of efforts to improve their cybersecurity and FDA says it aims to make that happen. Also: a Gray Sheet podcast interview with Katie Moussouris, chief policy officer with the San Francisco-based cybersecurity company HackerOne.
You may also be interested in...
FDA Says It Is Changing Its Cybersecurity Culture, And Others Should Too
Speaking at the 2015 mHealth Summit, Suzanne Schwartz, the FDA device center's top cybersecurity expert, said the agency is undergoing a cultural shift to better deal with device cybersecurity vulnerabilities and urged manufacturers, security researchers and hospitals to do the same.
EU Regulatory Assessors Get AI Boost In Reaching Scientific Decisions
The European Medicines Agency is training scientific staff working for the European medicines regulatory network in how to use a new AI-powered search engine that allows them to easily retrieve information on regulatory precedents.
EU Parliament Stricter Than Council On Medicines And Medical Devices Packaging
The EU Parliament's Environment, Public Health and Food Safety committee takes a compromise position with regards to the Packaging and Packaging Waste Directive. Medicines and medical devices should be exempt, but only until 2035, at which point the European Commission should check whether the development of materials and the recycling process have progressed, and may adjust this exemption accordingly.