Regulation of Health IT

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Health IT Now Comments on FDA Software Guidance

Health IT Now issued the following statement in response on the Food and Drug Administration (FDA) draft guidance entitled Software as a Medical Device (SAMD): Clinical Evaluation:“Health IT Now appreciates the international community’s continued work on health IT regulation.

Health IT Now Responds to FDA Software Comments

Today, Robert Horne, Executive Director of Health IT Now (HITN), issued the following statement in response to Dr. Jeff Shuren’s comments on the FDA regulatory pathway for software products:“Health IT Now commends Dr. Shuren for his comments today outlining the potential of a system of pre-checked quality controls as a solution to the issue of software modifications.

Health IT Now Comments on FDA Draft Guidance

On July 18, 2016, Health IT Now submitted comments in response to the FDA’s draft guidance entitled Use of Electronic Health Record Data in Clinical Investigations. Click here to read our comments.

Health IT Now and Apervita Release White Paper on Thought Conference Findings

Today, Health IT Now (HITN) and Apervita released a white paper on the establishment of key health care areas discussing the promise of data in health care and identifying barriers and challenges related to federal regulation and interoperability of health IT.

Health IT Now Commends Senate HELP Committee

Health IT Now (HITN) issued the following statement commending the Senate HELP Committee on passing the Medical Electronic Data Technology Enhancement for Consumers’ Health (MEDTECH) Act:

“HITN thanks the Senate HELP Committee for passing this important piece of legislation with broad bipartisan support.

Health IT Now Urges Senate HELP Committee to Pass the MEDTECH Act

WASHINGTON, D.C. – Today, Robert Horne, Senior Vice President of Health IT Now (HITN), issued the following statement:

“HITN applauds the work of the Senate HELP Committee in seeking to advance the MEDTECH Act.

Health IT Now Applauds Senate HELP Committee

FOR IMMEDIATE RELEASE:
Contact: Catherine Pugh
(202) 808-8843
Email: cpugh@healthitnow.org
1.20.

Chicago Conference Highlights Need for Reform

While Silicon Valley is still famous in the tech industry, Chicago has recently seen a boom in innovative start-ups. From Groupon, to Avant, to GrubHub, Chicago is home to many of the most transforming technologies of the past decade.

Health IT Now Comments on SOFTWARE II

Health IT Now sent a comment letter to Congressman Blackburn and Congressman Green on the revised SOFTWARE draft. HITN believes the Committee has substantial opportunities to promote innovation by clearly defining the products subject to FDA review and those products that are not. The latest draft is the clearest, best written bill on the subject we have seen to date.

HITN Comments on FDASIA Report

Health IT Now filed a comment offering feedback on the proposed risk-based regulatory framework and strategy for health IT, as summarized in the FDASIA Report. The full comment letter can be found here.

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