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. 

RSS icon

ONC publishes wave six of 2014 draft test procedures

The Office of the National Coordinator for Health IT (ONC) has released wave six of the draft test procedures for the 2014 edition of EHR certification criteria and is inviting the public to comment.

FDA seeks to speed up 510(k) process

The FDA has issued guidance regarding the Medical Device User Fee Amendment of 2012 and the agency’s intention to use additional revenues from fees to reduce turnaround time for 510(k) submissions.

Connected Health: Preventive health in the workplace

BOSTON—As healthcare costs rise for employees and employers alike, businesses are finding new ways to engage patients in the workplace, according to the panelists of an Oct. 26 presentation at the ninth annual Connected Health Symposium.

Connected Health: FDA inaction may do more harm than good

BOSTON—Pharmaceutical companies don’t make drugs like they used to. The FDA should let them, according to Juan Enriquez, MBA, managing director of Excel Venture Management and former founding director of the Harvard Business School Life Sciences Project, who spoke Oct. 25 at the ninth annual Connected Health Symposium, hosted by Partners HealthCare.

Connected Health: Can accountable care reverse healthcare spending trends?

BOSTON—Spending more does not equal better care. Accountable care can reverse that trend, Elliot S. Fisher, MD, MPH, said during an Oct. 25 presentation at the ninth annual Connected Health Symposium, hosted by Partners HealthCare in Boston.

Stringent quality measures fail to measure care provided

ONC releases wave five of 2014 draft test procedures

The Office of the National Coordinator for Health IT (ONC) published wave five of the draft test procedures for the 2014 edition of EHR certification criteria and is inviting the public to comment.

Professional associations suggest guiding principles for SGR replacement

Dozens of professional healthcare associations are listed on an Oct. 15 letter to Sens. Max Baucus (D-Mont.) and Orrin Hatch (R-Utah), both members of the Senate Committee on Finance, calling for an end to the sustainable growth rate (SGR) formula and offering suggestions for alternatives.

Displaying 3361 - 3368 of 3407

Around the web

Cardiovascular Business
FDA says years-long tirzepatide shortage is resolved, will give limited leeway to compounders

The tirzepatide shortage that first began in 2022 has been resolved. Drug companies distributing compounded versions of the popular drug now have two to three more months to distribute their remaining supply.

AI in Healthcare
From Capitol Hill to a hospital near you? 5 federal recommendations for healthcare AI policy

The 24 members of the House Task Force on AI—12 reps from each party—have posted a 253-page report detailing their bipartisan vision for encouraging innovation while minimizing risks. 

Cardiovascular Business
Merck spends up to $2B to license new weight loss drug with potential heart benefits

Merck sent Hansoh Pharma, a Chinese biopharmaceutical company, an upfront payment of $112 million to license a new investigational GLP-1 receptor agonist. There could be many more payments to come if certain milestones are met.