Regulation of Health IT

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Health IT Now Statement on HHS Budget Request

Health IT Now Executive Director Joel White commented today on early summaries of the Trump’s administration Department of Health and Human Services (HHS) budget for the coming fiscal year. The administration’s full budget document is set to be unveiled tomorrow.

Health IT Now Comments on FDA Real-World Evidence Draft Guidance

Today, Health IT Now submitted comments on the Food & Drug Administration’s draft guidance entitled Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices. Click here to read the full comment letter.

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Health IT Now issued the following statement in response on the Food and Drug Administration (FDA) draft guidance entitled Software as a Medical Device (SAMD): Clinical Evaluation:“Health IT Now appreciates the international community’s continued work on health IT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Health IT Now Comments on FDA Draft Guidance

On July 18, 2016, Health IT Now submitted comments in response to the FDA’s draft guidance entitled Use of Electronic Health Record Data in Clinical Investigations.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

Contact: Catherine Pugh
(202) 808-8843

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.

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