Concierge Medicine v. Direct Primary Care: Legal Issues

Concierge medicine and direct primary care both raise legal issues, though they present different models in terms of how they handle insurance.

Telemedicine legal definitions and informed consent requirements vary by state

Telemedicine legal and regulatory issues are complicated by the fact that there are numerous legal definitions of telemedicine.

Does the FDA Regulate Mobile Apps Designed for Health and Wellness?

Health and wellness mobile apps and online programs raise a variety of legal and regulatory issues that require legal expertise in structuring a health education or healthcare products or [...]

FDA issues warning letter to dietary supplement company for including cancer or diabetes in search field

The FDA issued a warning letter citing a dietary supplement company for its online content.In its warning letter to dietary supplement manufacturer M.D.R. Fitness Corp., the FDA warned that [...]

FDA takes aggressive stance on dietary supplement promotion and labeling

The FDA has taken an aggressive stance on dietary supplement promotion and labeling in recent warning letters involving dietary supplement manufacturers' and distributors' response to consumer [...]

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 [...]

Licensing proposed for medical staffing agencies

A Maryland legislative Committee has called for require state licensing of medical staffing companies after a radiographer was accused of exposing hundreds of Maryland citizens to hepatitis C.

California Medical Board proposes changes to physician supervision rules for elective cosmetic procedures

The California Medical Board, on its page for proposed regulations, has proposed to amend California law to provide regarding physician supervision of elective cosmetic procedures.

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 [...]

FTC settles charges based on mobile device data breach

The FTC put out a press release on a settlement regarding data breaches on mobile smartphones and cellphones.

Sample Business Associate Agreement Under HIPAA Omnibus Rule for HIPAA Compliance

HHS has issued a sample business associate agreement under the Omnibus Rule, with caveats.

FTC Prohibits pomegrenate juice disease claims

The Federal Trade Commission issued a final order prohibiting POM Wonderful, maker of POM pomegranate juice products, from claiming that any of its products is effective in diagnosing, treating, [...]

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 7 (Notice of Privacy Practices & Other Provisions)

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 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 [...]