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Data Breaches Can Result in Federal and State Liability

Regulatory bodies continue to impose severe penalties on covered entities who fail to protect patient data from unauthorized disclosure. Community Health Systems, Inc. recently settled claims with HHS Office of Civil rights resulting from a 2014 data breach that exposed personal information of approximately 6.1 million patients for $2.3 million. But settlement with the federal […]

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Alert

Two charged in prescription and kickback scheme

An 11-count indictment unsealed on Friday charges former Kindred Home Health employee Amber Price, 37, and Christopher Cruz, 46, owner of a medical marketing business, CP Cruz Management Group, LLC (Cruz), with one count of conspiracy to violate the federal anti-kickback law. Under the alleged scheme, Price and Cruz would create fraudulent prescriptions using actual […]

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Alert

Medical Device Maker to Pay $18 Million to Settle Allegations of Improper Payments to Physicians

This is not a Texas company, but it is a good example of how some manufacturers try to cloak improper payments under the veil of legitimate compensation. The device manufacturer paid millions of dollars in “advertising assistance, practice development, practice support, and purported unrestricted educational grants” directly to local healthcare providers to induce sales of […]

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Alert

OCR Settles Eighth Investigation in HIPAA Right of Access Initiative

Since 2019, the Office for Civil Rights (OCR) at the U.S. Department of Health and Human Services (HHS) has been prioritizing enforcement actions against covered entities that do not allow patients timely access to their health records at a reasonable cost as required by HIPAA. This month, OCR settled an eighth investigation for $160,000 and […]

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Alert

VIDEO: TBCE Stem Cell Stakeholder meeting

Stem Cell Stakeholder meeting of the Texas Board of Chiropractic Examiners from Tuesday, October 13, 2020.

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Alert

HHS Renews Public Health Emergency Declaration through January 20, 2021

On Friday, October 2, the U.S. Department of Health & Human Services (HHS) announced that the Public Health Emergency (PHE) declaration for COVID‑19 will be renewed for another 90 days, beginning on October 23 (the date the PHE was previously scheduled to expire) and extending through January 20, 2021. Source: Renewal of Determination That A […]

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Presentation

VIDEO: Bad Batch of Miracle Cure: Texas Response to Stem Cell Therapies

A presentation I gave to the Dallas Bar Association, Health Law Section on stem cell regulation in Texas.

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Alert

Professional Relators Have No Right to Sue for Beneficial Conduct

The Seventh Circuit determined that professional qui tam relators formed as “investment vehicles for financial speculators” should not be allowed to challenge conduct determined by the government likely to be lawful, and definitely beneficial to the government and the public. The court creates a new standard for dismissal, joining the standards articulated in Sequoia Orange […]

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Alert

FDA Clarifies Types of Evidence Relevant to Determining the “Intended Use” of FDA-Regulated Products

The FDA proposed updates to clarify the types of evidence it considers when determining the “intended use” of a product. A product’s “intended use” determines whether it is a medical product within the FDA’s jurisdiction. The proposed updates allow any source to be considered, even the subjective knowledge of the manufacturer. The proposed update clarifies, […]

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Alert

FDA Will No Longer Review EUA Requests for COVID-19 Laboratory Developed Tests

The Food and Drug Administration (FDA) will no longer require premarket review of laboratory developed tests (LDTs), including COVID-19 tests, decline to review emergency use authorization (EUA) request for LDTs. Instead, the FDA will prioritize review of EUAs for point-of-care tests, home collection tests, at-home tests, tests that reduce reliance on test supplies, and high-throughput, […]