Electronic health record (EHR) vendor Allscripts recently disclosed on an earnings call that it has reached a tentative agreement with the Department of Justice (DOJ) to pay $145 million to settle an investigation into the regulatory compliance of one of its recent acquisitions, Practice Fusion. This news, combined with DOJ’s other recent successful enforcement actions against EHR companies, represents a trend and should be a warning that compliance is a priority when it comes health IT. We anticipate that there will be more Anti-Kickback, HIPAA, and False Claims Act cases against similar health IT targets in the pipeline.

Allscripts acquired Practice Fusion, also an electronic health record company, in February 2018. According to the company’s public SEC filing from the first quarter of 2019, the investigation “relates to both the certification Practice Fusion obtained in connection with the U.S. Department of Health and Human Services’ Electronic Health Record Incentive Program and Practice Fusion’s compliance with the Anti-Kickback Statute and HIPAA.”


Continue Reading Allscripts Close to Reaching Deal with DOJ for Health IT Certification, Anti-Kickback Statute, and HIPAA Issues

Building on momentum from Administrator Seema Verma’s announcement of the MyHealtheData initiative at HIMSS 2018, CMS has published more clues as to future action to liberate health information for patients.

In the CY 2019 call letter to Medicare Advantage organizations and Part D programs, CMS describes the Blue Button 2.0 project and its use of

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.)
Continue Reading Liberating Data to Transform Value-Based Care: MyHealthEData, Blue Button 2.0, and Price Transparency

This morning, the Food and Drug Administration released highly anticipated guidance on clinical and patient decision support that has been in the works at the agency for several years, advising the digital health community about how it plans to regulate software that offers recommendations or feedback to its users—both healthcare professionals, and patients and caregivers. It also provides guidance on FDA’s interpretation of new software provisions in Section 3060 of the 21st Century Cures Act.

Given the explosion of these innovative digital health tools and their strong potential to transform healthcare, this guidance is a significant development for tech companies and investors focusing on this space. Comments will be accepted for 60 days.
Continue Reading FDA Issues New Guidance for Clinical and Patient Decision Support Software

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

The HHS Office of Civil Rights published a new FAQ response (OCR FAQ) detailing the agency’s position that generally information blocking will violate the HIPAA Privacy and Security Rules if it affects a covered entity’s access to its own protected health information (PHI) or its ability to respond to requests for access to PHI from patients. This follows a series of similar policy documents from HHS over the past 18 months that focus on preventing business arrangements or practices that would be defined as information blocking, and thereby, frustrating the goal of interoperability. Specifically, according to the OCR FAQ:

  • An electronic health records (EHR) vendor or cloud provider’s actions to terminate a covered entity’s access to its own electronic PHI (ePHI) (e.g., in a payment dispute) would violate the HIPAA Privacy Rule because those actions would constitute an impermissible use of PHI.
  • An EHR vendor or cloud provider’s refusal to ensure the accessibility and usability of a covered entity’s ePHI upon demand by the covered entity or to return a covered entity’s ePHI upon termination of the agreement, in the form and format that is reasonable in light of the agreement, would violate the HIPAA Security Rule.
  • A business associate may not deny a covered entity access to the PHI the business associate maintains on behalf of the covered entity if necessary to provide individuals with access to their PHI under the HIPAA Privacy Rule.
  • A covered entity that agrees to terms within a business associate agreement (BAA) that would prevent the covered entity from ensuring the availability of its own PHI as required would not be in compliance with the HIPAA Privacy and Security Rules.

OCR has increasingly ramped up its enforcement of violations of the HIPAA Privacy and Security Rules related to noncompliant BAAs, so the new OCR FAQ signals that information blocking provisions could be the source of future enforcement actions.


Continue Reading Blocking Access to Health Information May Violate HIPAA

On July 19th, the Office of the National Coordinator for Health Information Technology (“ONC”) released a report expressing concerns about major gaps in policies and oversight surrounding the access to, security, and privacy of health information held by certain mobile health (“mHealth”) technology companies and health social media.  While the report frames the

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:


Continue Reading The Rise of the One-Stop Shop? ONC Outlines Four Mechanisms to Help Providers Compare Certified Health IT Products

Congress set its sights on achieving the widespread exchange of health information through interoperable-certified electronic health records (“EHR”) by declaring it a national objective in the Medicare Access and CHIP Reauthorization Act of 2015 (“MACRA”). To accomplish this goal, MACRA directs the Department of Health and Human Services (“HHS”) to establish metrics in consultation with

The Office of the National Coordinator for Health Information Technology (“ONC”) began the month of March and the HIMSS Annual Conference with the announcement of an unexpected proposed rule, the Enhanced Oversight and Accountability Rule (the “Oversight Rule”). The Oversight Rule would expand ONC’s role in the ONC Health IT Certification Program (“Program”). Specifically, the Oversight Rule provides ONC with express powers to directly review health IT certified under the Program and employ review, suspension, and termination processes to address “non-conformities” found in certified health IT.  The ONC is seeking comment on key issues such as the scope of ONC’s proposed direct review authority, its processes for reviewing certified and uncertified health IT capabilities, and the agency’s potential overlap with the authority of other agencies.  All public comments will be due to ONC on or before May 1, 2016.

As stated in the ONC’s press release, the Oversight Rule focuses on three areas: Direct Review, Enhanced Oversight, and Greater Transparency and Accountability.


Continue Reading The ONC Proposes the Direct Review of Certified Health IT in Oversight Rule