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Get Your Story Straight: Patent Office Cracks Down on Inconsistent Statements Made Before the FDA

Bill of Health

In the July 29, 2022 notice, the USPTO set forth its views on the “duty of disclosure” and “duty of reasonable inquiry,” emphasizing the importance of consistency between statements made to the USPTO, the FDA, and other governmental agencies. Background Context.

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Healthcare Supplier Compliance Checklist

MedTrainer

While adherence to these guidelines is voluntary, organizations implementing effective compliance programs are better equipped to identify and address potential compliance risks, mitigate fraud and abuse, and uphold the integrity of healthcare programs and services. Ensure compliance with licensing agreements and software usage terms.

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Digital Health in the Metaverse: Three Legal Considerations

Healthcare Law Blog

These advancements, present challenges and raise novel questions as to how the current healthcare and life sciences legal regime would apply to the metaverse. In response to the growth of the metaverse and digital health generally, the FDA has been working to expand its guidance in the area. Data Privacy and Security.

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Key Legal Issues Facing Telehealth Platforms, as Compliance Concerns Bubble for Platforms Launched During the Public Health Emergency

Health Care Law Brief

For example, New York continues to maintain a professional licensing waiver that enables certain providers, licensed out of state, to render care within the state, for the duration of the declared state of emergency. Variety of Risks Present in Telehealth Arrangements. Provider Licenses.

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OIG Advisory Opinion Alert: Medical Flights for Patient Access

Healthcare Law Blog

First, the Biologics License Application approval letter from the U.S. Food and Drug Administration (“FDA”) approved only a single manufacturing facility, which is located on the campus of the “Treatment Center.” Thus, the Drug can be administered only at the Treatment Center by a qualified surgeon.

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States and Feds Signal Big Changes to Telehealth Prescribing

Health Law Advisor

On February 14, 2023, the Utah Senate passed a bill that would repeal the State’s “Online Prescribing, Dispensing, and Facilitation Licensing Act” (“Online Prescribing Act”). 2] Statements of Charges may be found on the Washington State Department of Health website, filed under the individual provider’s name and/or license number.

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Health Provider News

Hall Render

fraud scheme Nursing home must face vaccine-related wrongful firing claim, but not $2M retaliation accusations Transgender woman sues employer, Harvard Pilgrim for discrimination MICHIGAN 48-unit senior housing development could go up next to Vicksburg Halls in Marysville Can ads help a Michigan nursing home fix a staffing crisis?