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News 12/17/25

December 16, 2025 News No Comments

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FDA updates its policy to accept de-identified real-world evidence to support drug and device application reviews. This change allows use of registries, insurance claims, and EHR data that were previously excluded because they lacked patient-level confidential information.

FDA says it intends to review the same policy change in its guidance for drug and biologics.


Reader Comments

From Dr.SickandTiredHIT: “Re: Texas versus Epic. Can we all just say the quiet part out loud? A conservative politician, who is running for statewide office and is looking to make a splash, is suing a company led by a liberal in a liberal city. The Texas v. Epic suit is nonsense beyond a politician trying to score points. Why can’t Epic say that?”


Sponsored Events and Resources

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Acquisitions, Funding, Business, and Stock

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Virtual cardiology company Auxira Health raises $7.8 million in seed funding. Auxira offers cardiology practices remote services that include access to advanced practice providers, care coordination, patient engagement, medication management, and system integration. MedStar Health (MD) launched Auxira in May through a collaboration with Abundant Venture Partners.

Healthcare technology, analytics, and services vendor Sentact acquires event and incident management company Performance Health Partners and Vizient’s Patient Safety Organization. Performance Health Partners founder and CEO Heidi Raines will join Sentact as chief strategy officer.

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Lin Health announces $11 million in Series A funding. The company offers an app-based treatment program for the management of chronic pain.

The private equity owners of Netsmart will reportedly seek a buyer for the company for the second time.

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Medify Health, which offers remote patient monitoring and chronic care management services for Medicare beneficiaries, shuts down.


Sales

  • WellSpan Health will expand its use of Aidoc’s clinical AI beyond radiology to include its nine hospitals and 250 outpatient facilities.
  • The Tampa General Hospital Cancer Institute (FL) selects Reimagine Care’s virtual cancer care services.
  • Mt. San Rafael Hospital and Clinics (CO) will implement Oracle Health, apparently replacing Medhost in the 25-bed hospital.
  • Berlin, Germany-based Charité, which is Europe’s largest university hospital at 3,000 beds, will implement Epic in a $235 million project.

People

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Rakshay Jain, MBA (Innovaccer) joins DexCare as chief product officer.


Announcements and Implementations

Tebra incorporates DrFirst’s RxInform prescription notification tool into its EHR+ for private practices.

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South Gippsland Hospital in Australia implements Altera Digital Health’s Sunrise EHR.

Children’s Minnesota will outsource its revenue cycle management to Ensemble Health Partners.

Manifest MedEx will provide the California Mental Health Services Authority with ADT notifications for people who are being seen by county behavioral health organizations.

Health insurer Fallon Community Health plan sues Innovaccer, alleging that the company’s software was worthless, didn’t improve risk adjustment revenue as promised, and was sold under fraudulent misrepresentation.


Government and Politics

PenRad Technologies will pay $530,000 to settle federal allegations that it violated the False Claims Act by inadvertently causing providers to bill Medicare and MassHealth for medically unnecessary breast cancer screenings due to an overlooked software setting. Intelerad Medical Systems acquired PenRad in 2022.

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Members of the House Veterans’ Affairs Technology Modernization Subcommittee voice concern over the soaring cost of the VA’s Oracle Health–based EHR Modernization program. The estimate has grown from an initial $10 billion to $37 billion, and the Institute for Defense Analyses projects at least $50 billion. Thirteen facilities are slated to go live next year, with full deployment expected by 2031. Subcommittee chair Tom Barrett (R-MI), a US Army veteran, has a personal stake in the rollout because four Michigan facilities that he uses for care will be the first to adopt the system since the 2023 pause.

An ASTP blog post outlines the similarities and differences between TEFCA and CMS-Aligned Networks.


Other

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University of California researchers find that automated outreach to patients offering help with advance care planning significantly increases the number of patients who complete ACP documentation.


Sponsor Updates

  • CloudWave names Maria Graham business development manager.
  • WellSky and UMed partner to expand home-based patient access to national clinical research registries.
  • Wolters Kluwer Health releases a new report titled “Future Forecast: The Growing Impact of PAs in the Healthcare System.”
  • Clinical Architecture releases a new episode of “The Informonster Podcast” titled “Inside Informatics with John D’Amore.”
  • Linus Health names Julie Wood, MD, MPH senior medical director, clinician engagement.

Blog Posts


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