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. 

FDA to Congress: Final mobile medical app guidance coming by end of fiscal year

In the third of three Senate Energy & Commerce Committee hearings on health IT, Christy Foreman, director of device evaluation in FDA’s Center for Devices and Radiological Health, promised the release of the agency's final guidance on its oversight over medical mobile apps (MMAs) by the end of this fiscal year. Looming regulatory uncertainty dominated discussion with healthcare and mobile industry witnesses during the past two hearings, with many urging FDA to finalize its 2011 draft guidance detailing its oversight approach.

Gilfillan defends CMMI, promises results at Senate hearing

Interim results from new payment and delivery models tested by the Center for Medicare and Medicaid Innovation (CMMI) are forthcoming within a year with recommendations for payment and care changes to follow within two years, Richard Gilfillan, MD, director of the center, told the Senate Finance Committee during a March 20 hearing. 

CMS: Act now to get incentives, avoid payment adjustment

The Centers for Medicare & Medicaid Services (CMS) webinar being offered several times this week had a specific purpose: to explain to providers how their decision to participate in several federal programs or put off participation could affect their incentive payments and payment adjustments in coming years.

HHS seeks feedback from entities in HIPAA audit program

The Department of Health and Human Services (HHS) is seeking feedback from entities on their involvement in a 2012 Office of Civil Rights HIPAA audit program. Survey results will inform the HHS as it embarks on a permanent program, as required by the HITECH Act.

Report: 29 states failing at transparent healthcare pricing

More than half of U.S. states are failing at transparency when it comes to disclosing costs for healthcare services, according to Health Care Incentive Institute and Catalyst for Payment Reform’s March 18 report on state price transparency laws.

CIO Q&A: Standards could ease stress of breakneck HIT pace

CIOs around the country have a lot on their plate right now, according to Marc Probst, vice president and CIO of Intermountain Healthcare in Salt Lake City. Probst spoke about one of the biggest issues in health IT, Meaningful Use, at the Health Information Management Systems Society annual meeting in New Orleans, and Clinical Innovation + Technology recently caught up with him to get his take on how the initiative is rolling out.

CMS releases guidance on state partnership exchanges

The Centers for Medicare & Medicaid Services (CMS) released a 57-page guidance document for qualified health plan issuers participating in federally-facilitated state partnership exchanges, which are set to go live October 2013.

Legislators seek clarity on FDA oversight of mobile medical apps

With the growth of the tablet and smartphone market, U.S. House of Representatives Energy and Commerce Committee members requested clarity from the Food and Drug Administration (FDA) on its regulatory authority over mobile medical applications, and whether mobile device manufacturers could be subject to excise taxes pursuant to the Patient Protection and Affordable Care Act (PPACA).

Around the web

The American College of Cardiology has sent a letter to HHS Secretary Robert F. Kennedy Jr. that outlines some of the organization’s central priorities and concerns. 

One product is being pulled from the market, and the other is receiving updated instructions for use.

If the Trump administration continues taking a laissez-faire stance toward AI—including AI used in healthcare—why not let the states go it alone on regulating the technology?