Regulation of Health IT

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Health IT Now Statement on MACRA Proposed Rule

WASHINGTON, DC (June 21, 2017): Health IT Now – a broad-based coalition of patient groups, provider organizations, employers, and payers supporting health information technology to improve patient outcomes – responded today to the proposed rule for implementing the second year of the Quality Payment Program under the Medicare Access and CHIP Reauthorization Act (MACRA).

Health IT Now Statement on FDA Digital Health Innovation Plan

WASHINGTON, DC (June 15, 2017): Health IT Now – a broad-based coalition of patient groups, provider organizations, employers, and payers supporting health information technology to improve patient outcomes – responded today to the Food and Drug Administration’s (FDA) announcement of a “new Digital Health Innovation plan” to “advance policies that promote the development of safe and effective me

Health IT Now Sends Letter to HHS Secretary Price on Priorities for New Administration

Health IT Now – a broad-based coalition of patient groups, provider organizations, employers, and payers supporting health information technology to improve patient outcomes – sent a letter today to Secretary of Health and Human Services (HHS) Tom Price outlining the advocacy group’s regulatory priorities for use of health IT within the new administration.

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Health IT Now Comments on FDA Real-World Evidence Draft Guidance

Today, Health IT Now submitted comments on the Food & Drug Administration’s draft guidance entitled Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices.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Health IT Now issued the following statement in response on the Food and Drug Administration (FDA) draft guidance entitled Software as a Medical Device (SAMD): Clinical Evaluation:“Health IT Now appreciates the international community’s continued work on health IT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.

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