News & Analysis as of

Health Care Providers Software

Orrick, Herrington & Sutcliffe LLP

Medical Devices, Cybersecurity & The False Claims Act: What are the Key Takeaways from the Illumina - DOJ Settlement?

Illumina, Inc., a publicly-traded biotechnology company, agreed to a $9.8 million settlement with the U.S. Department of Justice (DOJ) in response to alleged violations of the False Claims Act (FCA). DOJ alleged that Illumina...more

Spilman Thomas & Battle, PLLC

Decoded - Technology Law Insights, V 5, Issue 10, December 2024

Happy Holidays and welcome to our year-end issue of Decoded. We hope you enjoyed reading our technology law insights e-newsletter this year. We are already planning for 2025. ...more

Goodwin

Texas AG Reaches First-of-its-Kind Settlement With Healthcare AI Company Over Hallucination Rate Claims

Goodwin on

In a recent settlement, the Texas attorney general resolved allegations that Pieces Technologies, Inc. (Pieces), a healthcare generative AI company, misrepresented the hallucination rate of its generative AI product to...more

Mogin Law LLP

Major Electronic Medical Records Firm ‘Squashing’ Competition, Antitrust Suit Claims

Mogin Law LLP on

Case pits newcomer against colossus said to control as much as 80-90% of the market. Particle Health Inc., a young healthcare data platform provider, has filed an antitrust complaint against Epic Systems Corp., the dominant...more

Holland & Knight LLP

Novel Settlement Reached in Generative AI Deceptive Trade Practices Healthcare Investigation

Holland & Knight LLP on

The state of Texas, by and through its Attorney General Ken Paxton, reached a first-of-its-kind settlement agreement with Pieces Technologies Inc. (Pieces) following an investigation into Pieces' alleged violations of the...more

Pillsbury - Policyholder Pulse blog

Narrowing the Professional Services Exclusion: Policyholder Lessons “Arising Out of” Practice Fusion v. Freedom Specialty...

A recent decision by a California appellate court in Practice Fusion, Inc. v. Freedom Specialty Insurance Company, denying the policyholder more than $118 million in Directors & Officers liability coverage based on an...more

Benesch

AI Reporter - August 2024

Benesch on

Google and Microsoft are spearheading the Coalition for Secure AI, focusing on supply chain security and mitigation strategies. Whether this attempt at self-regulation will ultimately succeed is unknown, as it overlaps with...more

A&O Shearman

Telemedicine software under scrutiny – German court classifies dermatology software as class IIa medical device under the MDR

A&O Shearman on

Telemedicine is getting more and more relevant to the healthcare industry, offering unprecedented access to medical services and enhancing patient care. However, telemedicine software providers often struggle with the...more

Mintz

Healthcare Provider Beware: Massachusetts Federal Court Largely Permits Tracking Technologies and Wiretapping Claims To Proceed

Mintz on

In the privacy world, pixels, cookies, and tracking technologies get all the attention these days. Plaintiffs and regulators alike have been working to persuade courts nationwide that the presence of third-party tracking...more

McDermott Will & Schulte

CMS Issues Guidance on Usage of AI in Making Coverage Determinations

On February 6, 2024, the US Centers for Medicare & Medicaid Services (CMS) issued a letter to all Medicare Advantage (MA) organizations and Medicare-Medicaid plans. The letter covered frequently asked questions and answers...more

Holland & Hart LLP

To BAA or Not to BAA: Must You Have One?

Holland & Hart LLP on

HIPAA applies to both covered entities (e.g., healthcare providers and health plans) and their business associates. A “business associate” is generally a person or entity that “creates, receives, maintains or transmits”...more

Health Care Compliance Association (HCCA)

Privacy Briefs: October 2023

Report on Patient Privacy 23, no. 10 (October, 2023) Kaiser Foundation Health Plan Inc. and Kaiser Foundation Hospitals will pay California $49 million to resolve allegations that they unlawfully disposed of hazardous waste,...more

Jones Day

Vital Signs Digital Health Law Update | Summer 2023

Jones Day on

We bring you Vital Signs, a curated, one-stop resource on the most notable digital health law updates from our U.S. and global contributors. In Industry Insights, we take an in-depth look at generative artificial intelligence...more

Foley & Lardner LLP

Software as a Medical Device (SaMD): Health Care Regulatory Considerations

Foley & Lardner LLP on

Sophisticated clinical software systems employed in specific health care services have graduated from being interfaces, operating systems, and subordinate tools that support physical medical devices and have matured to the...more

Epstein Becker & Green

FDA Oversight of AI Software Developed by Health Care Providers

Epstein Becker & Green on

Introduction - Hardly a day goes by when we don’t see some media report of health care providers experimenting with machine learning, and more recently with generative AI, in the context of patient care. The allure is...more

Cozen O'Connor

Whistleblower Watch - A quarterly update on FCA Enforcement and Qui Tam Litigation

Cozen O'Connor on

Summer 2023- Whistleblower Watch is a comprehensive source for all False Claims Act (FCA) news and information. Every quarter, Cozen O’Connor will provide in-house counsel and compliance professionals with a summary of the...more

Health Care Compliance Association (HCCA)

Privacy Briefs: June 2023

Privacy Briefs: June 2023 - Long-term care pharmacy network PharMerica disclosed a breach involving more than 5.8 million patients, making it the largest breach reported to the HHS Office for Civil Rights (OCR) in the last...more

Fox Rothschild LLP

Brightree and MatrixCare Support Interoperability

Fox Rothschild LLP on

Brightree by ResMed (“Brightree”), a cloud-based management software platform for healthcare providers, has conducted its biannual interoperability survey, and issued its corresponding biannual Interoperability and Engagement...more

Ankura

FDA Authorized to Establish New Cybersecurity Standards for Medical Devices: What it Means for Industry

Ankura on

On December 29, 2022, President Biden signed a new statute that will significantly impact medical device cybersecurity regulation. Section 3305 of the Consolidated Appropriations Act of 2023 (“Section 3305”) authorizes the...more

Womble Bond Dickinson

Artificial Intelligence - The Promise of Early Disease Diagnosis and Improved Treatment and the Potential of Liability

Womble Bond Dickinson on

If there is one thing that everyone can agree on, it is that health is an important factor in life. In 2021, over 3 million people died in the United States with heart disease and cancer topping the list....more

Barnea Jaffa Lande & Co.

How to Maintain Patient Privacy when Digitally Transferring Medical Information

Barnea Jaffa Lande & Co. on

The Israeli Privacy Protection Authority (PPA) recently published a document for public comments entitled, “Protecting Patients’ Privacy When Transferring Medical Information via Digital Devices and Undesignated Software.”...more

Goodwin

FDA Issues Final Clinical Decision Support Software Guidance

Goodwin on

​​​​​​​On September 28, 2022, the U.S. Food and Drug Administration (“FDA” or “the Agency”) issued its long-awaited final guidance, “Clinical Decision Support Software” (the “CDS Guidance”). The CDS Guidance follows the...more

King & Spalding

FDA’s Final Clinical Decision Support Guidance: The Good News and the (Really) Bad News

King & Spalding on

On September 28, 2022, the U.S. Food & Drug Administration (“FDA” or the “Agency”) published the long-awaited final guidance, “Clinical Decision Support Software” (the “Final CDS Guidance”). The Final CDS Guidance supersedes...more

McDermott Will & Schulte

FDA Issues Long-Awaited Final Clinical Decision Support Software Guidance

On September 28, 2022, the US Food and Drug Administration (FDA) issued its final Clinical Decision Support Software Guidance three years after the issuance of its 2019 revised draft guidance. The final guidance refines and...more

Foley & Lardner LLP

Developers Take Note: FDA Issues Clinical Decision Support Software Final Guidance

Foley & Lardner LLP on

On September 27, 2022, the Food and Drug Administration (FDA) issued its much anticipated final guidance for industry and FDA Staff, Clinical Decision Support Software. This guidance follows the draft Clinical Decision...more

44 Results
 / 
View per page
Page: of 2

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
- hide
- hide