The Food and Drug Administration (FDA) has announced several new initiatives that reflect its ongoing commitment to maintain patient safety, while also championing the need and opportunity for health care innovation.

During opening day of Health Datapalooza, FDA Commissioner Scott Gottlieb highlighted the critical import of novel digital health tools in achieving patient-centered care, and outlined how the agency is committed to moving the ball forward in health care innovation through the following initiatives:
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Despite the Trump Administration’s declaration of a state of emergency on October 26, 2017, the federal response to the opioid crisis largely languished on the back burner—much to the chagrin of states in the trenches of the opioid epidemic. However, based on the flurry of activity over the past several weeks, the federal government response now seems to be gathering substantive momentum, with various agencies and government actors launching attacks on all fronts—administrative, legislative, and enforcement alike. The federal government’s recent efforts present opportunities for health care organizations, life sciences companies, and health tech companies to get involved at the ground level to help influence opioid policy and provide needed products, services, and support to reduce the incidence of opioid abuse and address the health care needs of patients.

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On March 6, 2018 at the Healthcare Information and Management Systems Society (HIMSS) 2018 conference, Centers for Medicare & Medicaid Services (CMS) Administrator Seema Verma announced a new initiative furthering the current Administration’s focus on value-based care and increasing patient access to healthcare data. The initiative — called MyHealthEData — will be led by the White House Office of American Innovation, in collaboration with the Department of Health and Human Services (HHS), CMS, the Office of the National Coordinator for Health Information Technology (ONC), the National Institutes of Health (NIH), and the Department of Veterans Affairs (VA). (CMS press release here.)
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On September 26, 2016, the Office of the National Coordinator for Health Information Technology (ONC) released guidance, entitled EHR Contracts Untangled, to help providers navigate the complexities of electronic health record (EHR) vendor contracting. The guidance breaks down important considerations for selecting EHR systems, and provides strategic pointers – including sample contract language

Earlier this month, the Office of the National Coordinator for Health Information Technology (ONC) released a report to Congress on the feasibility of creating tools to help providers compare and select certified health IT products. As part of the Medicare Access and CHIP Reauthorization Act (MACRA), Congress required ONC to conduct a study to examine the feasibility of establishing mechanisms to assist providers in comparing and selecting certified EHR technology products. Congress suggested that ONC consider mechanisms like establishing a website of aggregated survey results that would allow meaningful EHR users to directly compare the functionality of certified health IT products. Congress also suggested compiling information from vendors of certified health IT products, and making that information publicly available in a standardized format.

In response to its Congressional directive, and drawing upon recommendations from the Certified Technology Comparison (CTC) Task Force, public input, and its own market analysis, ONC’s report focused on two subgroups of the health care community – providers and comparison tool developers – and identified specific problem areas in the comparison tool marketplace. Ultimately, the report proposed four mechanisms to improve the health IT comparison marketplace:


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Continuing to usher in a new wave of EHR technology changes, on September 11, 2014, the Office of the National Coordinator for Health Information Technology (“ONC”) adopted the “2014 Edition Release 2” final rule, which provides alternative criteria and approaches for the voluntary certification of heath information technology. The final rule, effective October 14, 2014[1], introduces regulatory flexibilities and general improvements to the certification processes.

First, the rule adopts a new (albeit smaller) subset of optional EHR Certification Criteria. Of the 57 proposed certification criteria in the February 26, 2014 notice of proposed rulemaking, the final rule adopts only ten optional and two revised EHR Certification Criteria. The Certification Criteria changes include:


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On September 4, 2014, the Department of Health and Human Services (“HHS”) published a final rule modifying the Medicare and Medicaid Electronic Health Record (“EHR”) Meaningful Use Incentive Program. The modification brings welcome change, allowing increased flexibility while also assuaging several provider concerns.

The new rule, effective October 1, 2014, comes in response to numerous public comments lamenting the inability of providers to meet the 2014 meaningful use objectives—an inability that brought with it financial penalties. As part of the new rule, HHS made four distinct changes to the EHR Incentive Program:

1. Altered the meaningful use stage timeline and definition of certified electronic health record technology (“CEHRT”). The new rule implements a one-year extension of Stage 2 for providers that first joined the Program in 2011 or 2012. The timeline to begin Stage 3 has thus been postponed until 2017. In keeping with this timeline shift, HHS also formally modified the CEHRT definition to reflect this date change, thus postponing until 2015 the required start date for exclusive use of 2014 Edition CEHRT.


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The Centers for Medicare & Medicaid Services (“CMS”) recently announced that it had identified and contacted more than 300,000 people to obtain proof of their citizenship or legal residency status. Failure to provide this documentation by September 5 could result in these individuals losing their Affordable Care Act (“ACA”) health coverage, effective September 30. This

The U.S. Department of Health and Human Services (“HHS”) Office for Civil Rights (“OCR”) announced in an April 22, 2014, press release that two separate entities—Concentra Health Services (“Concentra”) and QCA Health Plan, Inc. (“QCA”)—collectively have paid almost $2 million to resolve potential violations of the Health Insurance Portability and Accountability Act of 1996