Physician Run and Physician Driven Practices – Part 1
Experienced healthcare lawyers advise doctors, physicians, and medical practices or a full range of regulatory and compliance issues including HIPAA, Stark Law, and the AKS.
Anti-Kickback Statute and Stark Law Settlements Worth Millions
The DOJ reported several new cases in which health care companies and doctors agreed to pay millions to settle claims of healthcare fraud due to AKS and Stark violations.
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 [...]
When Healthcare Entrepreneurs & Medical Doctors Collaborate, Corporate Practice of Medicine Legal Issues Rule
Jill’s healthcare venture requires her to source a medical doctor (MD) who can collaborate with Jill’s startup to provide a series of innovative healthcare therapies to users
June Roundup of FDA and FTC Warning Letters To Healthcare Companies Claiming COVID 19 Treatments and Cures
The Federal Trade Commission (FTC) and Federal Drug Administration (FDA) are continuing to send warning letters to companies that promise treatments and cures for COVID-19
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.
Proposed Regulatory Framework for Modifications to Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD) – Part Two
Key provisions of the FDA’s proposed regulatory framework of software that uses and adapts to artificial intelligence and machine learning
Mitigate Legal Quagmires While Digital Health Opportunities Expand Your Healthcare Practice and Business by Following These Core Legal Rules
Mitigate Legal Quagmires While Digital Health Opportunities Expand Your Healthcare Practice and Business by Following These Core Legal Rules
California Healthcare Laws and Agencies that Doctors, Health Providers, and Health Companies Should Know Regarding Patient Healthcare Rights
Medical providers and healthcare companies need to know numerous rules that govern the products and services the providers offer. Health providers need to pay special attention to the needs of [...]
FTC Warning Letters Target IV Therapy and Vitamin C Therapy Claims for Unsubstantiated COVID-19 Treatments
Federal Trade Commission is sending warning letters after reviewing company websites, social media, and marketing materials for unsubstantiated claims that therapies can prevent, or cure COVID-19.
Proposed Regulatory Framework for Modifications to Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD)
The FDA has a new proposal for approving AI and ML software that looks at the total product lifecycle from development to post-market uses and the adaptations the software learns
FTC Sends 45 Warning Letters to Companies Making False Claims that their Products and Treatments Can Prevent or Cure COVID-19
The Federal Trade Commission sent 45 more warning letters to businesses for falsely claiming their supplements, herbs, and other products and therapies could prevent to treat COVID-19
How the California Consumer Privacy Act Affects the Healthcare Industry
The California Consumer Privacy Act Affects the Healthcare Industry goes into effect on January 1, 2020. Failure to comply with the data protection requirements can result in fines and penalties.
Strong Compliance Plans for Small Medical Practices
OIG Compliance guidelines for physicians (MDs, Dos) and small medical practices
The FDA’s Frequently Asked Questions about the Regulation of Cannabis and Cannabis-Derived Products, Including Cannabidiol (CBD) – Part Two
More FDA answers to questions about cannabis-derived CBD drugs, foods, dietary supplements and food products including access to CBD for clinical investigations.
FDA Policy on When Software that Uses Artificial Intelligence and Machine Learning qualifies as a Medical Device
As more artificial intelligence products become available, the FDA is reevaluating its approval criteria. For now, De novo approval and 501(k) are being used along with premarket approval.
FDA Warning Letters To Companies Claiming Products Boost Immunity and Treat COVID-19
Federal Drug Administration continues to send warning letters to companies that boast products can treat, diagnose, prevent, or cure COVID-19 or boost immunity.
Physician Recruitment Agreements Obligate the Hospital, Medical Practice and the Physician – Make Sure You Know What Your Obligations Are
Physician recruitment agreements involve the rights and duties of three parties. Experienced healthcare lawyers craft the proper exceptions to the Anti-Kickback Statute and Stark Law
FDA Warning Letters Sent to Companies That Claim Products are Effective against COVID-19
Federal Drug Administration has started sending warning letters to companies that boast their products can treat, diagnose, prevent, or cure COVID-19 or boost immunity.
FTC COVID-19 Warning Letters
The Federal Trade Commission (FTC) announced the agency is sending warning letters to companies that claim its products can treat or prevent coronavirus (COVID-19) due to lack of scientific evidence
