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. 

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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.

Congressman introduces bill to reform Medicare auditing program

Rep. Samuel Graves (R-Mo.) introduced legislation Oct. 16 to reform the Medicare Recovery Audit Contractor (RAC) program, which the American Hospital Association (AHA) has criticized for “wasting hospital resources and contributing to growing health care costs.”

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Around the web

Cardiovascular Business
Boston Scientific enters renal denervation market with acquisition worth up to $540M

Boston Scientific has announced another significant M&A deal, scooping up an Israeli medtech company focused on RDN technology. 

Radiology Business
Shift toward imaging outside the hospital could save billions

Harvard’s David A. Rosman, MD, MBA, explains how moving imaging outside of hospitals could save billions of dollars for U.S. healthcare.

Cardiovascular Business
FDA announces catheter recall for Johnson & Johnson PFA system due to stroke risk

The recall comes after approximately 3% of patients treated with the device during the early stages of its U.S. rollout experienced a stroke or transient ischemic attack following surgery. The expected stroke rate is closer to 1%, the FDA explained.