FDA now requires a cyber security plan in your medical device submission. On June 14, 2013, FDA issued Draft Guidance on Content of Premarket Submissions for Management of Cybersecurity in [...]
The Federal Trade Commission (FTC) requires that advertising be truthful and not misleading, and will take enforcement action if mobile app developers make deceptive claims about their apps.
Michael H. Cohen participated in the LARTA Commercialization Assistance Program in Los Angeles (April 2013), sponsored by the National Institutes of Health, as a mentor to provide guidance to [...]
Healthcare reform is creating incentives for even more legislative scrambles by different practitioner lobbying groups for favorable legislation that will protect, preserve, and expand their own [...]
A federal court in Indiana rules that patient's HIPAA and state privacy claims could stand, based on the allegation that a physician shared information about the patient's medical condition with [...]