Innovation

New Artificial Intelligence-Based Risk Score May Help Avoid Unnecessary COVID-19 Hospitalizations

Researchers at Massachusetts General Hospital (MGH) have developed a diagnostic tool that uses artificial intelligence to generate a score to assess the prognosis of individual patients diagnosed with … [Read more...]

Industry Trends

Surging COVID-19 Cases Are Pushing Laboratories to the Breaking Point

Long lines for testing. Shortages of critical testing supplies. Case backlogs and long reporting delays. Laboratories across the country and the patients they serve are reliving the nightmares of … [Read more...]

Enforcement Scorecard

The HIPAA Information Access Rights Crackdown Continues

The face of federal HIPAA enforcement has changed in a subtle but significant way in the past 18 months. Historically, the focus has been all about keeping personal health information (PHI) private … [Read more...]

M&A Report

Exact Sciences Makes a Bold Double Play to Bolster Its Early Cancer Detection Capabilities

Although volume was light, October was a robust month for M&A deal making in terms of impact, especially in the cancer diagnostics space. The month started with the announcement of Invitae’s … [Read more...]

FDA Watch

Agency Temporarily Allows Modifications of Influenza and RSV Tests Without Premarket Notification

On Oct. 13, the FDA issued new guidance on molecular diagnostic tests for influenza and respiratory syncytial virus (RSV). The upshot of the guidance is to temporarily allow makers of flu and RSV … [Read more...]

HIPAA

OCR Cracks Down on Providers Who Don’t Provide Individuals Timely Access to PHI

The HIPAA Privacy Rule requires labs and other health care providers to provide persons on whom they keep health records and other protected health information (PHI) timely access to that information … [Read more...]

Top of the News

Major Insurer Claims It Has No Obligation to Pay for Pooled COVID-19 Testing

Free COVID-19 testing is a powerful and very compelling policy. The problem, of course, is that somebody has to pay for coronavirus testing. And the insurance companies have been designated as that … [Read more...]

Enforcement Trends

Granston Memo Whistleblower Dismissals May Be Tougher than DOJ Thought

In 2018, the Justice Department sent an internal memorandum ordering US Attorneys to aggressively seek to dismiss False Claims Act (FCA) whistleblower qui tam lawsuits that lack merit or don’t serve … [Read more...]

Emerging Tests

FDA Offers New Guidance on Validating SARS-CoV-2 Tests in “Non-Laboratory” Settings

SARS-CoV-2 testing in homes, workplaces, airports, schools, sports venues and other non-traditional diagnostic settings is likely to play an increasingly important role in the months ahead. The FDA … [Read more...]

Labs In Court

Rhode Island Health System Fined +$1 Million for Failure to Encrypt Laptops

Case: The trouble began when Lifespan Corporation, the parent company of a Rhode Island-based non-profit health system filed a breach report after a laptop containing medical record numbers, … [Read more...]


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