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.

Covid Consumer Protection Act

A new law, the Covid-19 Consumer Protection Act, authorizes the US DOJ and FTC to enforce deceptive marketing claims about the prevention, cure, treatment, mitigation, and diagnosis of COVID-19.

Non-Compete Clauses And Restrictive Covenants For Health Practices

The Biden Administration announced an executive order to increase competition and limit non-compete contracts. Skill healthcare providers advocate for doctors who leave medical practices.

COVID-19 Vaccination Requirements and Laws

The US Centers for Disease Control and Prevention has clinical care guidelines for the three vaccines that have been approved – the two mRNA vaccines and the Jansen vaccine.

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.

How Have States Relaxed the Telemedicine Requirement of a Good Faith or Appropriate Prior Exam?

Many states are easing the restrictions on using telehealth during COVID including easing licensing requirements and in-person visit requirements.

Additional State Telehealth Waivers During the COVID-19 Pandemic. Part Three.

Many states, such as Illinois, Iowa, Massachusetts, Minnesota, New Jersey, and North Carolina, are easing the restrictions on using telehealth serviced during the COVID pandemic.

Johnson and Johnson’s COVID-19 Vaccine Should Be Reviewed by FDA Soon

Johnson & Johnson’s adenovirus-based vaccine for preventing the transmission of COVID-19 is expected to be reviewed by the Food and Drug Administration in February 2021.

Additional State Telehealth Waivers During the COVID-19 Pandemic. Part Two.

Many states, such as Florida, Kansas, Kentucky, Michigan, and New York are easing the restrictions on using telehealth serviced during the COVID pandemic.

Stark Law Blanket Waivers during COVID

The Centers for Medicare & Medicaid (CMS) identified 18 waivers to Stark Law’s prohibition against self-referrals. The waivers are based on the form of remuneration and the type of financial [...]

FDA Warning Letters – COVID-19 Testing Kits

FDA is sending warning letters to companies that claim the company can diagnose COVID-19. FDA has granted an Emergency Use Authorization) for at least one at-home testing kit.

FDA Reviewing Moderna’s COVID-19 Vaccine

An Advisory Panel for the Food and Drug Administration is reviewing a request by Moderna for its COVID-19 vaccine. Moderna’s vaccine is expected to be distributed in the coming months.

FDA Approves Authorized Use of a COVID-19 Test Product

FDA granted emergency use authorization to Lucira Health Inc. for a COVID-19 self-testing kit. The EUA has numerous conditions that the manufacturer must meet.

FDA Issues Emergency Use Authorization for Pfizer COVID-19 Vaccine

FDA granted an Emergency Use Authorization to a COVID-19 vaccine developed by Pfizer, Inc. Doses of the vaccine have already been administered to health workers

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

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.

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

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.

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

page 1 of 2