Cybersecurity

FDA and CISA need to update cyber agreement for medical devices, watchdog says

The Government Accountability Office said medical devices are not commonly hacked but still called them “a source of cybersecurity concern warranting significant attention.”

Cybersecurity

CISA and HHS look to help the health sector ramp up cyber hygiene

Agency resources are intended to address the longstanding challenges health systems and hospitals have faced from increasingly advanced cyberattacks.

Emerging Tech

FDA forms new committee to advise on health tech

The FDA is taking nominations for the Digital Health Advisory Committee, which is expected to begin work next year.

Artificial Intelligence

Can AI boost health care delivery?

Rep. Ted Lieu thinks so, with the right oversight by humans — and government.

Cybersecurity

FTC, HHS warn of potential privacy and security risks embedded in online health sites

The agencies noted hospitals and telehealth providers could be exposing sensitive patient health information through online tracking tools like Meta Pixel and Google Analytics.

Artificial Intelligence

FDA Announces Contract for Automation in Drug Performance Analyses

The Food and Drug Administration is asking for proposals for automated devices that can provide high-definition imaging and critical analyses of drug performance as the agency works to integrate more AI.

Artificial Intelligence

FDA Wants to use AI to Assess Pharmaceuticals

The agency is looking for a small business to provide the service to help examine freeze-dried pharmaceuticals and complex generic drug products.

Digital Government

CDC Seeks Digital Health App for Its Employees

The mobile application should provide meditation and mindfulness activities to help employees manage stress.

Emerging Tech

FDA Set to Issue Final Rule Classifying VR Therapy Device for Pain Relief

The FDA said the class II designation for AppliedVR’s virtual reality medical device for the treatment of chronic lower back pain will “enhance patients’ access to beneficial innovation.”

Policy

Lawmakers Explore 'More Permanent Direction' for Telehealth Under Medicare

Many of Medicare’s telehealth provisions were tied to emergency pandemic measures, which will come to an end.

Artificial Intelligence

Adoption of AI in Health Care Relies on Building Trust, DOD, VA Officials Say

Wider use of health-related artificial intelligence applications at the departments of Veterans Affairs and Defense depends on technologies being “sufficiently understandable.”

Cybersecurity

NIST to Launch New Guidance on Security Risks of Telehealth and Smart Home Integration

The agency notes that “user experience” improvements may come with less control over privacy and security.

Modernization

Over 20,000 Veterans Received VHA iPads but Never Used Them for Virtual Care

An inspector general review found that the agency was also slow to get devices back so they could be redistributed.

Cybersecurity

Diabetes Patients Flood FDA with Comments on Cybersecurity for Medical Devices

As the agency finalizes guidance for approving the sale of devices such as those used to monitor and control glucose levels, the comments highlight competition and consumer protection issues associated with a grassroots movement for the “right-to-repair.”

Modernization

GAO dismisses final CIO-SP4 protests

Awards will be announced by Nov. 1, and the ordering period of CIO-SP3 and CIO-SP3 small business will be extended.

Emerging Tech

VA Continues Healthcare Modernization With Simulated Employee Training

Officials are seeking industry input for SIMPLE, a pending platform to help train VA employees virtually.

Artificial Intelligence

AI Teaches Brain Tumor Surgery Better Than Human Experts

Artificial intelligence tutors are outperforming human instructors.