Office of the National Coordinator for Health Information Technology

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

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

As digital health innovation continues to move at light speed, both new and incumbent stakeholders find themselves on a new frontier—one that challenges traditional health care delivery and payment frameworks, in addition to changing the landscape for product research, development and commercialization. Modernization of the existing legal framework has not kept pace with the rate of digital health innovation, leaving no shortage of obstacles, misalignment and ambiguity for those in the wake.

What did we learn in 2017 and what’s to come on the digital health frontier in the year ahead? From advances and investments in artificial intelligence (AI) and machine learning (ML) to the increasingly complex conversion of health care innovation and policy, McDermott’s Digital Health Year in Review details the key developments that shaped digital health in 2017, along with planning considerations and predictions for the health care and life science industries in 2018. 
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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

The Office of the National Coordinator for Health Information Technology recently released a report (the Report) detailing user experience research on patient access to health data. The Report sought to examine the experiences of 17 individuals and processes of 50 health systems, with commentary from four medical record fulfillment administrators, to determine how the medical record request process can be improved for consumers. The Report ultimately concludes that patients and health care providers alike are in need of a well-defined process that is convenient, expedient and transparent.

Background

The Health Insurance Patient Portability and Accountability Act (HIPAA) does not create a uniform process for storage and production of medical records across providers, and in-turn did not create a convenient request process for patients. Generally, patients have a right to access a designated record set, which includes 1) medical records and billing records about individuals maintained by or for a covered health care provider; 2) enrollment, payment, claims adjudication, and case or medical management record systems maintained by or for a health plan; and 3) other records that are used, in whole or in part, by or for the covered entity to make decisions about individuals. Upon receipt of a request by a patient to access their health records, the covered entity receiving the request must produce the records within 30 days. Prior to producing those records, however, the covered entity must verify the identity of the individual making the request. This often involves signature verification or similar processes.


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On December 7, 2016, the US Congress approved the 21st Century Cures Act (Cures legislation), which is intended to accelerate the “discovery, development and delivery” of medical therapies by encouraging public and private biomedical research investment, facilitating innovation review and approval processes, and continuing to invest and modernize the delivery of health care. The massive

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