Risk Management and Compliance for Direct-to-Consumer Genetic Testing Companies

Direct-to-consumer genetic testing companies must navigate complex FDA regulations, HIPAA compliance, and state laws to avoid enforcement actions. Learn how to structure your business legally, [...]

US HHS and HIPAA’s New Rule for Reproductive Health Care Disclosures

At the direction of the Biden-Harris administration, the US HHS issued a Final Rule prohibiting the disclosure or protected reproductive healthcare information unless an exception applies.

Patient Notification Requirements When Medical Practices Merge or are Acquired

Physicians and medical practices who merge their practices, sell, or acquire a medical practice need to notify their clients about the transaction so they can make informed decisions about their [...]

HIPAA Compliance for Pharmacies – Violations and FAQs

Pharmacies should consult with experienced healthcare lawyers to understand what conduct may qualify as a HIPAA violation, the penalties for violations, and to get answers to HIPAA compliance [...]

Why Posting Patient Photographs on Social Media Accounts May Violate HIPAA and FTC Advertising Regulations

Physicians and medical practices should review the HIPAA rules, FTC requirements, and local medical rules before posting any patient photographs on social media accounts. The civil fines for [...]

HIPAA Notification of Enforcement Discretion During COVID-19 Emergency Ends

The HHS Office for Civil Rights has ended the “discretionary” enforcement of HIPPA Rules violations of telehealth services during the COVID-19 public health emergency. Compliance is now required.

The Possibilities and Legal Risks of ChatGPT for Doctors and Medical Practices

ChatGPT will help doctors and medical practices keep better records, review medications, track diseases, and monitor patients. Healthcare providers need to understand the legal rules that govern [...]

Medical Image Analysis Software – Part One

New medical imaging software benefits many different types of health practices. Key compliance issues include HIPAA and FDA oversight.

Immunotherapy and Healthcare Compliance

Immunotherapy drugs are showing promise for treating cancer. Manufacturers of these therapies and doctors must understand the FDA, HIPAA, and other compliance requirements.

Durable Medical Equipment Compliance

Durable medical equipment companies need to review the Anti-Kickback Statute, Stark Law, HIPAA, CMS requirements, and other federal and state requirements before marketing their business.

Legal Compliance Issues for Integrative Cardiology

Integrative cardiology practitioners, doctors and non-physicians, need to review their working relationship for violations of state licensing laws, HIPAA, self-referral laws, and other legal [...]

Federal and California Laws that Protect Patient and Consumer Information

There are several federal and state laws that are designed to protect patient medical information. Violations of these laws can result in substantial fines and penalties.

FAQs About HIPAA and the Right of Access Part two

The US Department of Health and Human Services provides questions and answers to the HIPAA Privacy Rule’s Right of Access. These FAQs directly affect healthcare practices

FAQs About HIPAA and the Right of Access, Part one

The US Department of Health and Human Services provides questions and answers to the HIPAA Privacy Rule’s Right of Access. These FAQs directly affect healthcare practices.

HIPAA and Access. Legal Summary and Recent Investigations

The HHS Office of Civil Rights has guidance on how and when covered entities should respond to a right of access request for the personal health information of a patient.

Relaxing Vaccine Dosage and Food Label Requirements

The Food and Drug Administration issues a press release that said, even though the pandemic is severe, patients should receive the mRNA vaccines in two properly timed doses.

Artificial Intelligence and the Health Insurance Portability and Accountability Act of 1996 (HIPAA)

AI in the healthcare industry almost by definition, requires constant access to patient information. Developers and covered health providers need to understand when and how HIPAA applies to their [...]

A Summary of Federal and State Health Laws on the California Health and Human Services Website – Privacy, Breaches, and other Patient Right Issues

Doctors, medical practices, and health businesses in California need to be aware of the relevant federal and state laws that regulate their practice and industry – including those on the CHHS website.

Frequently Asked Questions about Telehealth and HIPAA during the COVID-19 emergency

The Department of Health and Human Services has created a list of frequently asked questions and answers about using telehealth during the COVID-19 emergency

HIPAA COVID-19 Decision Tool

The OCR of the DHHS announced a new online decision tool to help HIPAA covered entities understand protected health information compliance during the COVID-19 emergency

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