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Can We Expect to See ONC’s Final Rule on Information Blocking Soon?

A recent update to the Office of Management and Budget (OMB) website suggests that the answer is “yes”—though that depends on how one defines “soon.” According to its website, OMB received the Office of the National Coordinator for Health Information Technology’s (ONC’s) final rule, entitled 21st Century Cures Act: Interoperability, Information Blocking, and the ONC Health IT Certification Program, for review on October 28, 2019. Based on the rule title, it appears that ONC is ready to finalize its proposals concerning information blocking and related exceptions. Earlier this year, ONC issued a proposed rule that, among other things, proposed to define information blocking and establish seven exceptions to the broad prohibition for reasonable and necessary activities that should not be considered information blocking. For more information about the information blocking provisions of ONC’s proposed rule, see our On the Subjects here and here. OMB review is one...

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2018 Digital Health Data Developments – Navigating Change in 2019

Data privacy and security legislation and enforcement saw significant activity in 2018 and early 2019. McDermott's 2018 Digital Health Year in Review: Focus on Data report – the first in a four-part series – highlights notable developments and guidance that health care providers, digital health companies and other health care industry stakeholders should navigate in 2019. Here, we summarize four key issues that stakeholders should watch in the coming year. For more in-depth discussion of these and other notable issues, access the full report. EU General Data Protection Regulation (GDPR) enhances protections for certain personal data on an international scale. US-based digital health providers and vendors that either (a) offer health care or other services or monitor the behavior of individuals residing in the EU, or (b) process personal data on behalf of entities conducting such activities should be mindful of the GDPR's potential applicability to their...

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ONC Sends Information Blocking Proposed Rule to OMB

The Office of the National Coordinator for Health Information Technology (ONC) is one step closer to issuing its long-awaited proposed rule to implement various provisions of the 21st Century Cures Act, including proposed regulations distinguishing between prohibited health information blocking among health care providers and health information technology vendors and other permissible restrictions on access to health information. According to its website, the Office of Management and Budget (OMB) received ONC’s proposed rule for review on September 17, 2018. OMB review is one of the final steps in the process before a proposed rule is published in the Federal Register for public comments. OMB did not identify a deadline for completing its review. The agency generally has up to 90 days to complete its review, but can take less time than that. In addition to defining the scope of prohibited information blocking conduct, the proposed rule is likely to address...

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ONC’s De-Regulatory Announcement Aims at Enticing Industry to Adopt 2015 Edition Criteria

In September, the Office of the National Coordinator for Health Information Technology (ONC) announced that it is scaling back requirements for third-party certification of criteria related to certified electronic health record (EHR) technology (CEHRT). Going forward, ONC will allow health developers to self-declare their products’ conformance with 30 of the 55 certification criteria. ONC will also exercise discretion and not enforce the requirement that certification bodies conduct randomized surveillance of two percent of the health IT certifications they issue. Read “ONC’s De-Regulatory Announcement Aims at Enticing Industry to Adopt 2015 Edition Criteria.” Copyright 2017, American Health Lawyers Association, Washington, DC. Reprint permission granted.

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False Claims Act Settlement with eClinicalWorks Raises Questions for Electronic Health Record Software Vendors

On May 31, 2017, the US Department of Justice announced a Settlement Agreement under which eClinicalWorks, a vendor of electronic health record software, agreed to pay $155 million and enter into a five-year Corporate Integrity Agreement to resolve allegations that it caused its customers to submit false claims for Medicare and Medicaid meaningful use payments in violation of the False Claims Act. Read the full article.

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National Roadmap for Health Data Sharing: FTC Advocates Preservation of Privacy and Competition

On April 1, 2015, the Office of the National Coordinator for Health Information Technology (ONC), which assists with the coordination of federal policy on data sharing objectives and standards, issued its Shared Nationwide Interoperability Roadmap and requested comments.  The Roadmap seeks to lay out a framework for developing and implementing interoperable health information systems that will allow for the freer flow of health-related data by and among providers and patients.  The use of technology to capture and understand health-related information and the strategic sharing of information between health industry stakeholders and its use is widely recognized as critical to support patient engagement, improve quality outcomes and lower health care costs. On April 3, 2015, the Federal Trade Commission issued coordinated comments from its Office of Policy Planning, Bureau of Competition, Bureau of Consumer Protection and Bureau of Economics.  The FTC has a...

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