C&M Health Law

C&M Health Law

Analysis, commentary, and the latest developments in health care law and policy

Tag Archives: ONC

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

Posted in Health IT
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… Continue Reading

FDA Issues New Guidance for Clinical and Patient Decision Support Software

Posted in Digital Health, EHR, Health IT
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.… Continue Reading

ONC Releases New Guidance on Electronic Health Record Vendor Contracting

Posted in Health IT
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 – to… Continue Reading

Blocking Access to Health Information May Violate HIPAA

Posted in Health IT, HIPAA & Privacy
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… Continue Reading

Addressing Health Privacy and Security Gaps in ONC Report

Posted in Health IT, HIPAA & Privacy
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 issue well,… Continue Reading

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

Posted in Health IT
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… Continue Reading

Tell HHS How to Measure Interoperability

Posted in Health IT
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… Continue Reading

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

Posted in Health IT
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… Continue Reading

Health Information Blocking Leads to New Requirements and May Lead to Enforcement Actions

Posted in Fraud, Waste & Abuse, Health IT
The federal government has spent billions to promote adoption and “meaningful use” of health information technology (HIT). There is growing government interest in ensuring that HIT is used to support patient care, but doing so requires electronic exchange of information. Congress, the Department of Health and Human Services (HHS), and States have taken action to… Continue Reading

CMS and ONC Announce New Proposed Rules for Stage 3 of the Medicare and Medicaid EHR Incentive Program and HIT Certification Criteria

Posted in Health Care Reform & ACA, Health IT
On March 30, the Centers for Medicare & Medicaid Services (CMS) published a proposed rule (CMS Proposed Rule) detailing the policies it will introduce during Stage 3 of the Medicare and Medicaid Electronic Health Record (EHR) Incentive Program. In tandem with CMS’s publication, the Office of the National Coordinator for Health Information Technology (ONC) also… Continue Reading

ONC Announces New EHR Certification Criteria

Posted in EHR, HIPAA & Privacy
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],… Continue Reading