Today, Health IT Now submitted comments on the Food & Drug Administration’s draft guidance entitled Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices.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.
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On October 14, 2016, ONC released the final rule entitled ONC Health IT Certification Program: Enhanced Oversight and Accountability. The final rule outlines ONC’s plan for implementing enhanced oversight of certified health IT products via direct review. Health IT Now created a summary table of provisions of the proposed rule and correlating provisions of the final rule.
Today, Health IT Now sent a letter to Acting Administrator Slavitt urging CMS to move forward as soon as possible on implementing virtual groups, which were included in the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA). Click here to read the full letter.
Today, two final rules were released that will have a major impact on all sectors of the healthcare system, and an especially large impact on the health IT sector.
Health IT Now issued the following statement in response on the Food and Drug Administration (FDA) draft guidance entitled Software as a Medical Device (SAMD): Clinical Evaluation:“Health IT Now appreciates the international community’s continued work on health IT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 is pleased to announce its newest Steering Committee member, Teladoc, Inc.: “We are thrilled that Teladoc is joining our broad coalition of stakeholders. Our coalition believes that technology can create new opportunities for health plans and government programs to increase access to care and lower costs.
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.
Today, Health IT Now (HITN) submitted comments on the proposed Calendar Year 2017 Medicare Hospital Outpatient Prospective Payment System. Click here to read the full comments. HITN also submitted comments on the proposed Calendar Year 2017 Medicare Physician Fee Schedule. Click here to read the full comments.
Washington, DC – Today, Health IT Now (HITN) issued the following comment on Dr. Karen DeSalvo’s resignation as the head of the Office of the National Coordinator for Health Information Technology (ONC):
“We at Health IT Now have greatly enjoyed working with Dr.
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.