Pediatric Consent on FHIR.

BACKGROUND: Standardizing and formalizing consent processes and forms can prevent ambiguities, convey a more precise meaning, and support machine interpretation of consent terms. OBJECTIVES: Our goal was to introduce a systematic approach to standardizing and digitizing pediatric consent forms, which are complex due to legal requirements for child and legal guardian involvement. METHODS: First, we reviewed the consent requirements from the Arizona regulation, and we used 21 pediatric treatment consents from five Arizona health care organizations to propose and evaluate an implementation-agnostic Consent for Treatment Framework. Second, we assessed the adequacy of the Fast Healthcare Interoperability Resources (FHIR) to support the proposed framework. RESULTS: The resulting Consent for Treatment Framework supports compliance with the state consent requirements and has been validated with pediatric consent forms. We also demonstrated that the FHIR standard has the required expressiveness to compute the framework's specifications and express the 21 consent forms. CONCLUSION: Health care organizations can apply the shared open-source code and FHIR implementation guidelines to standardize the design of machine-interpretable pediatric treatment consent forms. The resulting FHIR-based executable models may support compliance with the law and support interoperability and data sharing.

Perceptions and Concerns of SUD Treatment Organizations Regarding the CARES Act's Alterations to Patient Confidentiality Regulations.

Objectives: Learn how substance use disorder (SUD) treatment organizations view and respond to changes in confidentiality and disclosure law following adoption of CARES Act Sec. 3221 and prior to promulgation of revised implementing regulations. Methods: Online survey followed by informal interviews. Representatives of SUD organizations reported their degree of awareness of Sec. 3221 provisions and their organizations' views on amendments to disclosure practices; current and future changes of organizational policies; difficulties anticipated in implementing new rules; and preferences for resources. Results: Forty informant surveys on 30 organizations completed. Participants (62.5 percent) indicated being somewhat knowledgeable about Sec. 3221. Evenly divided positive and concerned views on Sec. 3221 reflect tension between preserving confidentiality of patient records and improving coordination of care. Most (76.7 percent) reported organizational discussions on Sec. 3221. Some (30 percent) identified changes to make in near future. Over a third expected few or no barriers to implementing changes to privacy and disclosure practices, while most (64.7 percent) expected hindrances including complexity and tensions in the law, staff education, cost, technological adjustments, and changes in the ways SUD organizations interact with external organizations and individuals. To overcome barriers noted, participants expressed desire (66.7 percent) for teaching tools such as webinars and templates to follow. Conclusions: SUD treatment organizations began thinking of and planning for proposed changes well before expected implementation of Sec. 3221. Their concerns reflected practicalities of implementation, determining content of law, and wondering about the extent to which it solves problems (improving coordination of care among various providers) or endangered other goals (protecting confidentiality of SUD patient records).