Electronic Health & Medical Records, Health Data Guiding Developers through Foundational Federal Laws Applicable to Mobile Health Technology
Kathryn Marchesini | December 12, 2022
As you design, market, and distribute a mobile health (mHealth) app that your customers will use to collect, share, use, or maintain individuals’ health information, it is likely you have questions about what U.S. federal laws apply. You may also wonder which federal agencies oversee various aspects of mHealth — including how this varies by how individuals, their health plan, or health care providers will use the app. Depending on who is expected to use an app and how they will get and use the app (e.g.,
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Health Data, Health Innovation Addressing Evolving Health Information Technology Needs in Pediatric Care: Neonatal Abstinence Syndrome (NAS) Informational Resource (IR)
LaVerne Perlie | November 15, 2022
Hot off the presses, the Pediatric Health Information Technology: Neonatal Abstinence Syndrome Informational Resource (NAS IR) [PDF – 808 KB] is a new resource from ONC to support pediatric care and practice settings specific to neonatal abstinence syndrome. The NAS IR builds upon prior efforts included in the ONC Pediatric Health Information Technology Informational Resources (IR) for health IT developers and for health care providers, and includes information about the implementation of health IT and its use as part of delivering health care to infants experiencing withdrawal after maternal exposure to opioids and other substances during pregnancy.
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Health IT Implementation HITAC Recommendations on ONC Adopted Standards
Mike Berry | November 10, 2022
The Health Information Technology Advisory Committee (HITAC) recently submitted their final report and recommendations related to ONC adopted standards and implementation specifications referenced in federal regulations. The report and recommendations are based on the work of the HITAC’s 2022 Adopted Standards Task Force and are responsive to a 21st Century Cures Act (Cures Act) (42 U.S. Code § 300jj–13) provision that requires the national coordinator to convene stakeholders to review the existing set of adopted standards and implementation specifications and make recommendations with respect to whether to maintain the use of such standards and implementation specifications;
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Health IT Certification Program Actionable ways to meet the 2015 Edition Cures Update requirements
Laura M. Urioste | November 8, 2022
The 2015 Edition Cures Update made several changes to the ONC Health IT Certification Program (Certification Program), including new functionalities; new, removed, and revised criteria; and new requirements establishing the Conditions and Maintenance of Certification. This means that most health IT developers of certified health IT (certified health IT developers) will be required to update their certified Health IT Modules by December 31, 2022. As we approach this deadline, it is important to remember that meeting the Certification Program requirements and avoiding non-conformities is up to each certified health IT developer.
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Health Data OSTP, in Partnership with ONC, Seeks Input on Optimizing Data Capture for Clinical Trials
Micky Tripathi | October 31, 2022
This blog post is co-authored with Jennifer Roberts, Assistant Director for Health Technologies, White House Office of Science and Technology Policy, and Grail Sipes, Assistant Director for Biomedical Regulatory Policy, White House Office of Science and Technology Policy.
The COVID-19 pandemic demonstrated the need for a coordinated clinical trials enterprise, one that can swiftly characterize emerging viral threats and evaluate the effectiveness of vaccines, therapeutics, and other countermeasures across a diversity of trial participants.