Today, Health IT Now submitted comments on the Food & Drug Administration’s draft guidance entitled Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices.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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Health IT Now issued the following statement in response on the Food and Drug Administration (FDA) draft guidance entitled Software as a Medical Device (SAMD): Clinical Evaluation:“Health IT Now appreciates the international community’s continued work on health IT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.
On July 18, 2016, Health IT Now submitted comments in response to the FDA’s draft guidance entitled Use of Electronic Health Record Data in Clinical Investigations.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.
On July 14, the House Appropriations Committee approved the Labor, Health & Human Services, Education and Related Agencies (Labor-HHS) funding bill for Fiscal Year (FY) 2017. A number of health IT provisions were included, of which HITN created a summary.
On July 15, 2016 the proposed rule Medicare Program; Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Part B for CY 2017; Medicare Advantage Pricing Data Release; Medicare Advantage and Part D Medical Low Ratio Data Release; Medicare Advantage Provider Network Requirements; Expansion of Medicare Diabetes Prevention Program Model was published in the Federal Reg
On June 27, 2015, Health IT Now submitted comments on the Merit-Based Incentive Payment System (MIPS) and Alternative Payment Model (APM) Incentive under the Physician Fee Schedule, and Criteria for Physician-Focused Payment Models proposed rule. To read our comment letter, click here.
On June 22, 2016, Health IT Now sent a letter to House and Senate Leadership and Conferees for the Comprehensive Addiction and Recovery Act of 2016. The letter calls on Congress to include language on how states should implement standards for an interoperable Prescription Drug Monitoring Program. Click here to read the letter.