Regulation – Page 5 – Healthy Skeptic

Mar 16 2010

mobihealthnews

By Kevin Roche Headlines No Comments

Shortly after becoming available for download from the AppStore, MIMvista’s app was removed from the store – the reason? FDA regulation

Mar 15 2010

Wall Street Journal

By Kevin Roche Headlines No Comments

A Food and Drug Administration panel Friday narrowly backed the use of Medtronic Inc.’s “deep-brain stimulation” device in certain epilepsy patients.

Mar 15 2010

Wall Street Journal

By Kevin Roche Headlines No Comments

Third-party outsourcing programs have come under fire at the FDA – the agency is weighing whether to end it given questions the quality of the reviews

Mar 01 2010

mobihealthnews

By Kevin Roche Headlines No Comments

The Continua Health Alliance noted in a recent newsletter that the FDA believes new laws for connected health device regulations are neither likely nor needed

Feb 18 2010

Pioneer Press

By Kevin Roche Headlines No Comments

Manufacturers of pacemakers, drug pumps and other implants could be latest industry due for overhaul, as FDA takes a reviews how devices are approved.

Feb 18 2010

Wall Street Journal

By Kevin Roche Headlines No Comments

The FDA may tighten or eliminate several pathways for getting a medical device approved quickly amid concerns they have been overused by industry

Feb 12 2010

mobihealthnews

By Kevin Roche Headlines No Comments

FCC’s Dr. Mohit Kaushal, health care director for the National Broadband Taskforce outlines key issues that give the FCC pause when it comes to strengthening their investment in health IT

Feb 05 2010

Washington Times

By Kevin Roche Headlines No Comments

Nowhere will the effects of the out-of-control spending be greater than at federal regulatory agencies that act as a gatekeeper, or brake, on innovative products and technologies

Jan 27 2010

Wall Street Journal

By Kevin Roche Headlines No Comments

No matter what happens with the health care reform bill in Congress, life sciences investors and companies should brace themselves for a brand new world

Jan 11 2010

Wall Street Journal

By Kevin Roche Headlines No Comments

One of the main Democrat-on-Democrat bouts in their secret nonconference committee turns on who will regulate the insurance industry

Oct 08 2009

Ensuring Drug Safety

By Kevin Roche Commentary No Comments

Having taken heat on drug safety, the FDA has issued a new draft guidance on risk mitigation efforts by drug companies.

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Jul 16 2009

HIT and Privacy Laws

By Kevin Roche Commentary No Comments

Health information technology is being pushed as one of the key methods to improve health care and reduce costs, but government itself has created barriers to its adoption and utility.

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