Policy & Regulations

This channel includes news coverage of healthcare policy and regulations set by Congress, the states, Centers for Disease Control and Prevention (CDC), the Department of Health and Human Services (HHS), U.S. Food and Drug Administration (FDA), and medical associations and societies. 

Duke professors argue ACOs haven’t worked

Duke University professors Kevin Schulman, MD, and Barak Richman, JD, PhD, called on the CMS Innovation Center to focus on telemedicine and wearable devices, rather than accountable care organizations (ACOs) which integrate hospitals, to reduce the cost of care.

Pathway Health to get a tech upgrade through Virtual Health partnership

Pathway Health, a post-acute consulting firm, and Virtual Health, a population health management technology provider, have entered into a partnership that will provide Pathway with strategic consulting services to improve technology and payment models.

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Draft guidance from the Food and Drug Administration is seeking to clarify when medical device manufacturers need the agency’s approval to make changes to their products,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.

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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.

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.

Around the web

U.S. health systems are increasingly leveraging digital health to conduct their operations, but how health systems are using digital health in their strategies can vary widely.

When human counselors are unavailable to provide work-based wellness coaching, robots can substitute—as long as the workers are comfortable with emerging technologies and the machines aren’t overly humanlike.

A vendor that supplies EHR software to public health agencies is partnering with a health-tech startup in the cloud-communications space to equip state and local governments for managing their response to the COVID-19 crisis.

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