Health IT Pulse:


December 8, 2017  5:09 PM

FDA draft guidance clarifies oversight of mobile medical apps

Tayla Holman Tayla Holman Profile: Tayla Holman
FDA, mobile health

The Food and Drug Administration (FDA) has issued new draft guidance clarifying its oversight of mobile medical apps. Furthermore, the agency will loosen its regulations for certain technologies it has...

December 7, 2016  9:19 AM

The 21st Century Cures Act: Implications for Health IT

Kristen Lee Kristen Lee Profile: Kristen Lee
FDA, information blocking, Interoperability, precision medicine

The U.S. Senate passed the 21st Century Cures Act on Dec. 6, legislation that has some important implications for health IT including providing funding to

May 3, 2016  1:30 PM

CHIME plots ways to augment medical device interoperability

Alex Delvecchio Alex Delvecchio Profile: Alex Delvecchio
CHIME, device interoperability, FDA, Interoperability, ONC

The FDA is making an effort to increase medical device interoperability, but their current plan for achieving that objective isn't comprehensive enough, according to a group of healthcare CIOs and IT executives. The College of Healthcare Information Management Executives (CHIME) wrote a letter...

January 20, 2016  4:58 PM

FDA gets tougher on IoT medical device cybersecurity

Shaun Sutner Shaun Sutner Profile: Shaun Sutner
cybersecurity, FDA, Internet of Things, medical devices

Manufacturers and users of connected medical devices should take steps to ensure the cybersecurity of such devices, the FDA said in a new guidance document. The draft...

June 30, 2015  10:53 AM

FDA group to support combined EHR, electronic data capture systems

Alex Delvecchio Alex Delvecchio Profile: Alex Delvecchio
clinical information systems, EHR, EHR systems, FDA

Clinical research and patient information captured during treatment are kept in different electronic systems and by separate organizations. The U.S. Food and Drug Administration (FDA) wants to support...

June 23, 2015  3:12 PM

FDA makes a deal with online patient group to study patient-reported drug safety data

Alex Delvecchio Alex Delvecchio Profile: Alex Delvecchio
adverse event reporting, drug safety, FDA, patient engagement, social media

The U.S. Food and Drug Administration (FDA) is teaming up with the largest online patient network to collect and study patient-reported drug safety data. 0 Comments     RSS Feed     Email a friend

June 15, 2015  4:12 PM

New research: FDA-regulated digital health devices could save U.S. healthcare billions

Kristen Lee Kristen Lee Profile: Kristen Lee
Digital Health, FDA, Mobile devices

Last year, the FDA seemed to lean toward deregulation of wellness, wearable and

February 25, 2015  5:34 PM

FDA takes hands-off approach to wellness devices

Shaun Sutner Shaun Sutner Profile: Shaun Sutner
Apple, FDA

If you have a pacemaker in your chest, the FDA wants to make sure the device works correctly. But if you want to wear a Fitbit, the agency will leave you alone. In another sign that the FDA intends to assume a markedly hands-off policy when it comes to the wellness devices and programs that are...

February 24, 2015  1:39 PM

FDA funding leads to medical device surveillance plan

Alex Delvecchio Alex Delvecchio Profile: Alex Delvecchio
FDA, medical device regulation, medical device security, medical devices

Though it has a handle on measuring the safety and effectiveness of medical devices, the FDA isn't sure there's enough publically-accessible information for patients and clinicians to make fully-informed decisions about medical products. The road to a firm medical device surveillance policy began...

December 23, 2014  2:25 PM

FDA proposal would make healthcare professionals go online for drug info

Alex Delvecchio Alex Delvecchio Profile: Alex Delvecchio
FDA, medication labeling

Concerned that patient safety is at risk in the current system, the FDA formally suggests the healthcare industry change the way practitioners receive information about any medications they are prescribed. A recent FDA proposal outlines its plans to change the method of labeling of certain...

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