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The Difference Between Non-Solicitation and Abandonment Of Patients

Physicians who leave a practice need to balance any non-solicitation issues in their employment contracts with the need to inform patients that the patient may need a new doctor.

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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.

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Compliance Issues in the Emerging Field of Medical Tourism

American physicians are working to benefit from medical tourism by targeting patients to come to America and by setting up practices in foreign countries.

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Legal Compliance Issues for American Medical Tourism Health Practices

Physicians who wish to work in the medical tourism sector need to be careful to separate their medical tasks from their business and marketing tasks and to avoid fee-splitting issues

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.

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Legal Risk Issues in Regenerative Medicine and Anti-Aging Medicine

As the population ages, health providers and health companies are developing and expanding their regenerative medicine and anti-aging practices. As with all healthcare services and products, [...]

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The FDA Provides New Guidance on the “Minimal Manipulation and Homologous Use” of Cell and Tissue Products.

The FDA new guidelines on minimal manipulation include questions and answers. Meeting the minimal manipulation test can save companies a fortune in IND studies and clinical trial tests.

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FDA Issues Warning Letter to Company that Sells CBD Products Online and Through Social Media

FDA sends warning letter to a company because its website and social media accounts made claims about CBD products that suggest they are drugs or dietary supplements and were misbranded.

New HHS 21st Century Cures Act IT Rule – Part 2

These are two more of the non-fulfillment exceptions to the ONC rule. Another three fulfillment exceptions follow. The exceptions try to balance the ability of the developers and practitioners to [...]

New HHS 21st Century Cures Act IT Rule – Part 1

The Office of the National Coordinator for Health Information Technology (ONC), which is part of the Department of Health and Human Services, approved a final rule which implements certain [...]