Fee-splitting 101 for medical doctors, chiropractors, acupuncturists, and others

Is it fee-splitting to hire another medical doctor, chiropractor, acupuncturist, or other health care practitioner in your office and give them a "cut" of patient revenues? Fee-splitting, [...]

Michael H Cohen Speaks on FDA Legal Issues to SoCal IP

Healthcare & FDA attorney Michael H Cohen spoke in Woodland Hills, California to the SoCal IP Law Group on "Our Designer Future: How FDA Legal Issues Shape Human Health–From Medical Devices to [...]

Health & Wellness Lawyer Michael H Cohen Speaks in Saudi Arabia on U.S. Regulation of Complementary and Integrative Medicine

Healthcare & FDA attorney Michael H Cohen spoke in Riyadh, Saudi Arabia, at the invitation of the World Health Organization, the Gulf Cooperation Council, and the Saudi National Center for [...]

LegalZoom Publishes “Health Apps as Medical Devices: What It Means for Consumers”

"Health Apps as Medical Devices: What It Means for Consumers" by healthcare, FDA & business lawyer Michael H Cohen was published by LegalZooom in its online legal headlines on Technology. The [...]

Online HIPAA training developed by Cohen Healthcare Law Group

Register for online HIPAA compliance training. HIPAA mandates HIPAA training for those required to comply. All members of the workforce (including employees, volunteers, trainees, and others [...]

How Medicare.gov helps with legal review of concierge medicine services

The government's Medicare website is useful in performing a legal and regulatory review of what healthcare services a concierge medical practice might offer.

California Privacy and Security Requirements for Protected Health Information Add to HIPAA Burden

State privacy and confidentiality laws (such as California's) can add to the HIPAA compliance burden when handling protected health information (PHI).Data breaches are becoming increasingly [...]

FDA Attorney Michael H. Cohen Speaking on FDA Legal Issues at the Ventura BioScience Incubator

FDA Attorney Michael H. Cohen speaks on FDA Legal Issues at the Ventura BioScience Incubator on October 17, 2013.The talk will focus on FDA regulation of cosmetics, dietary supplements, and [...]

Caveman Blogger Has Procedural Win on Appeal of First Amendment Case on Unlawful Nutrition & Dietetics Charge

The 4th Circuit Court of Appeals in Cooksey v. Futrell has weighed in on the fate of the “caveman blogger.”Recall that in this case, the caveman blogger sued the North Carolina Board of Dietetics [...]

OIG Opines that services by LLC owned by podiatrist and wife do not violate anti-kickback laws

In Advisory Opinion 13-02, the U.S. Department of Health & Human Services, Office of Inspector General (OIG) issued a favorable opinion approving an arrangement whereby a podiatrist and his wife [...]

FDA Cybersecurity Plan Adds to Mobile App Developer FDA Compliance Burden

The FDA now requires that mobile app developers create a cyber security plan and submit it to the FDA along with their mobile medical app / medical device submission.

Concierge Medicine Today features “LEGAL: Concierge Medicine v. Direct Primary Care: Legal Issues”

Concierge Medicine Today, a leading digital resource for timely, trusted health news and concierge medical information, featured LEGAL: Concierge Medicine v. Direct Primary Care: Legal Issues.

FDA Mobile Medical App Guidance Reads FDA Medical Jurisdiction Expansively

The FDA's Mobile Medical App Guidance contains many nuanced definitions that determine whether your mobile app will likely be regulated by the FDA as a medical device.Recent clients have asked [...]

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 [...]

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.

From Telemedicine Everywhere to Telemedicine Anywhere: Legal & Regulatory Issues

American Telemedicine Association President-Elect Ed Brown, M.D., founder and CEO of the Ontario Telemedicine Network, coined this phrase at the American Telemedicine Association annual meeting.

Bloggers must take care to not provide clinical health advice

Attorney Michael H. Cohen was quoted in The Tan Sheet (2/25/13) in "Turning Blogger Relationships Into Gold Takes Careful Management," by Lisa Gillepsie

Retail medicine spreads through Walgreens

The practice of medicine outside traditional healthcare settings is expanding through retail settings such as Walgreens.

FTC Releases “.com Disclosures: How to Make Effective Disclosures in Digital Advertising”

The FTC's guidance for digital (online) advertising applies to all business advertising on websites, mobile phone applications, or anywhere online (i.e., including on Facebook, smartphones, etc.).

Wellness Programs Under the Affordable Care Act (“ACA”) and Related Federal Laws

Does health care reform discuss wellness and prevention?Yes, among other things, the Affordable Care Act (“ACA”) provides incentives for individuals to focus on wellness.