Cohen Healthcare Law Group Yelp attorney review

We appreciate a new review on Yelp for the Cohen Healthcare Law Group.

FDA Requires Cyber Security Plan Submission for Medical Devices

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 On June 14, 2013, FDA issued Draft Guidance on Content of Premarket Submissions for Management of Cybersecurity in [...]

Michael H Cohen quoted in Los Angeles Bar Journal

Michael H Cohen was quoted in the Los Angeles Bar Journal in the Legal Forum: Malpractice Malaise, an appendix to Attorney, Heal Thyself.

Mobile App Developers Can Be Slammed by FTC or FDA

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.

LARTA Commercialization Assistance Program

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 [...]

Affordable Care Act creates scope of practice legislative scramble for healthcare practitioners

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 [...]

HIPAA and state law privacy claims stand while medical malpractice claim falls

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 [...]

HIPAA Omnibus Rule: Part 8 (Breach Analysis)

The HIPAA Omnibus rule makes a number of additional important changes to breach analysis in case of a breach of unsecured PHI.

HIPAA Omnibus Rule: Part 6 (Business Associate Agreements)

The new HIPAA Omnibus Rule requires that some changes to the rules about business associate agreements must be made.

HIPAA Omnibus Rule: Part 5 (Privacy Rule Changes)

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 [...]

HIPAA Omnibus Rule: Part 4 (Security Rule Changes)

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 [...]

HIPAA Omnibus Rule: Part 3 (Enforcement & Penalties)

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 [...]

HIPAA Omnibus Rule: Part 2 (Business Associates & Subcontractors)

Business Associates and subcontractors have expanded obligations under the Omnibus Rule.

HIPAA Omibus Rule: Part 1 (Overview)

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 [...]

New HHS Rule Protects Patient Privacy Under HIPAA and HITECH

Much-anticipated regulation protects patient privacy under HIPAA and HITECH

Is it fee-splitting to share profits in an acupuncture, chiropractic, osteopathic, or MD physician group?

An acupuncture student from Northern California wrote in asking the following question about fee-splitting, kickbacks, Stark / self-referral, and group practices.

Off-label drug promotion and marketing yields significant penalties: Part 2 (Misbranding in interstate commerce)

Misbranding can also occur when a product is "held for sale after shipment in interstate commerce.

Off-label drug promotion and marketing yields significant penalties: Part 1 (Amgen settlement)

Off-label drug use is not illegal, but off-label drug promotion and marketing can result in significant legal penalties.

Weight Loss Advertisements Found Deceptive and Misleading – Conspiracy and Healthcare Fraud Violations

The 1-800-GET-THIN ad campaign is embroiled in a criminal investigation for healthcare fraud and other violationsThe FDA and FBI are investigating.

Cleveland Clinic promotes second medical opinion – telemedicine consults can fit legal exception

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 [...]