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Recent Headlines

FDA guidance addresses when device makers need to report changes

Draft guidance from the Food and Drug Administration is seeking to clarify when medical device manufacturers need the agency’s approval to make changes to their products, potentially replacing guidance that had remained unchanged since 1997.

Study: Only 15% of device companies ready for Sept. 24 UDI compliance deadline

A September 24 deadline set by the Food and Drug Administration is looming for Class II medical devices, such as condoms or wheelchairs, to be outfitted with unique device identifier (UDI) barcodes, but in a survey of device makers, only a few said their companies were currently compliant with the standard.

Q&A with AMDIS Award winner Peter Basch

Recently, the Association of Medical Directors of Information Systems (AMDIS) held their annual awards to recognize leaders in healthcare IT. Among those recipients was Peter Basch, MD, MACP, Senior Director for IT Quality and Safety, Research and National Health IT Policy at MedStar Health.

NIH could fund animal-human stem cell research

Injecting human stem cells into animal embryos will no longer make researchers ineligible for National Institutes of Health Funding, the agency announced August 4.

 
10 rural hospitals to test new Medicare payments for telehealth, skilled nursing

CMS has announced the ten rural hospitals participating in Frontier Community Health Integration Project (FCHIP) demonstration to test new delivery models in sparsely-populated areas, with the goal of treating more rural Medicare beneficiaries closer to home rather than having them travel long distances for care.

Period-tracking apps leave women vulnerable to data mining

Technology has seeped into nearly aspect of life, including health, which means millions of women use apps to track their menstrual cycles just as they use them to track train schedules.

 
Technology companies have a better view of your health than you might think

It’s a grudgingly accepted fact of life among many that specific personal data and more general meta data about nearly everyone is stored online, possibly accessible to people, corporations and governments willing to look for it.

 
FDA taking hands-off policy towards ‘low-risk’ health apps, devices

Fitness trackers and mobile apps that focus on “general wellness” won’t be regulated by the Food and Drug Administration (FDA), according to new guidance released by the agency, while warning that more invasive technologies still fall under its purview.

CMS star ratings debut with promise for continued updates

After several months of buildup, the CMS Hospital Compare website began to offer overall hospital star ratings July 27.

 
New FDA draft guidance seeks to clarify UDI forms

A new draft guidance from the U.S. Food and Drug Administration (FDA) seeks to clarify how Unique Device Identifiers (UDIs) are included on medical devices.

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