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 On June 14, 2013, FDA issued Draft Guidance on Content of Premarket Submissions for Management of Cybersecurity in [...]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 [...]
The HIPAA / HITECH Privacy Rule has been changed.Under the Modifications to the HIPAA Privacy, Security, Enforcement, and Breach Notification Rules under the Health Information Technology for [...]
The Modifications to the HIPAA Privacy, Security, Enforcement, and Breach Notification Rules under the Health Information Technology for Economic and Clinical Health Act and the Genetic [...]
The Modifications to the HIPAA Privacy, Security, Enforcement, and Breach Notification Rules under the Health Information Technology for Economic and Clinical Health Act and the Genetic [...]
The Department of Health and Human Services Office for Civil Rights (OCR) released its final rule, Modifications to the HIPAA Privacy, Security, Enforcement, and Breach Notification Rules under [...]
An acupuncture student from Northern California wrote in asking the following question about fee-splitting, kickbacks, Stark / self-referral, and group practices.
Cleveland Clinic is marketing an online second opinion service for patients who live outside Ohio but want medical input.There are many ways to take advantage of telemedicine laws to provide [...]