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DOI: 10.1055/a-1990-5157
Laboratory Results Release to Patients under the 21st Century Cures Act: The Eight Stakeholders Who Should Care
Abstract
A major aim of the 21st Century Cures Act is to support patients' access to their electronic health data and to prevent information blocking practices by health care organizations and health information technology developers. Prior to the Cures Act, significant variation existed in patient access to laboratory test results, key pieces of health data which enable timely self-management and engagement in care. Although many health care systems began releasing test results immediately through patient portals because of the Cures Act, implementation remains challenging due to variations in state regulations around electronic results release, local interpretations of allowable exceptions to Cures information blocking, concerns about privacy of sensitive laboratory results, and technological limitations. This paper outlines the eight stakeholder groups involved in implementation of electronic laboratory result release to patients and describes recommendations for these groups to consider in achieving the Cures Act goals to support a patient's access to their health information and control of their health care.
Keywords
patient portals - electronic health record - health information technology - clinical informatics - decision-making - laboratoryPublication History
Received: 22 August 2022
Accepted: 28 November 2022
Accepted Manuscript online:
30 November 2022
Article published online:
18 January 2023
© 2023. Thieme. All rights reserved.
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References
- 1 P.L. 114–255 Approved December 13, 2016 (130 Stat. 1033) 21st Century Cures Act. Compilation Of The Social Security Laws. Accessed July 12, 2022 at: https://www.ssa.gov/OP_Home/comp2/F114-255.html
- 2 Federal Register: 21st Century Cures Act: Interoperability, Information Blocking, and the ONC Health IT Certification Program. Accessed July 13, 2022 at: https://www.federalregister.gov/documents/2020/05/01/2020-07419/21st-century-cures-act-interoperability-information-blocking-and-the-onc-health-it-certification
- 3 Purington K, Alfreds ST, Pritts J, Buxbaum J. Electronic Release of Clinical Laboratory Results: A Review of State and Federal Policy. The California HealthCare Foundation; 2010. Accessed August 05, 2022 at: https://www.chcf.org/wp-content/uploads/2017/12/PDF-ElectronicLabResultsExchangePolicy.pdf
- 4 Lye CT, Forman HP, Gao R. et al. Assessment of US hospital compliance with regulations for patients' requests for medical records. JAMA Netw Open 2018; 1 (06) e183014
- 5 California Assembly Bill. AB-2253 Regular Session 2011-2012. Clinical laboratory test results: electronic conveyance. Accessed December 23, 22 at: https://leginfo.legislature.ca.gov/faces/billNavClient.xhtml?bill_id=201120120AB2253
- 6 214.181 Legislative findings–General consent to testing for HIV–Emergency procedures–Disclosures of test results–Voluntary testing programs in each county. Accessed August 08, 2022 at: https://apps.legislature.ky.gov/law/statutes/statute.aspx?id=49028
- 7 HIMSS. Confused about information blocking? Turn to the experts | Healthcare IT News. Accessed July 13, 2022 at: https://www.healthcareitnews.com/news/confused-about-information-blocking-turn-experts
- 8 HealthIT.gov. Information Blocking. Accessed July 13, 2022 at: https://www.healthit.gov/curesrule/final-rule-policy/information-blocking
- 9 HIMSS. Confusion remains about ONC information blocking rules, even after start date | Healthcare IT News. Accessed July 13, 2022 at: https://www.healthcareitnews.com/news/confusion-remains-about-onc-information-blocking-rules-even-after-start-date
- 10 TechTarget. Status, Challenges of Information Blocking Rule Compliance. Accessed July 13, 2022 at: https://healthitsecurity.com/features/status-challenges-of-information-blocking-rule-compliance
- 11 Public Health Institute. Understanding Confidentiality and Minor Consent in California: an adolescent provider toolkit. Accessed August 05, 2022 at: https://www.phi.org/thought-leadership/understanding-confidentiality-and-minor-consent-in-california-an-adolescent-provider-toolkit/
- 12 Health Affairs. The Promise Of Health Information Technology In 2022 | Health Affairs. Accessed August 03, 2022 at: https://www.healthaffairs.org/do/10.1377/forefront.20220217.71427/#:~:text=In%20short%2C%20the%20Cures%20Act,170.404
- 13 Health Affairs. Provider Obligations For Patient Portals Under The 21st Century Cures Act | Health Affairs. Accessed August 03, 2022 at: https://www.healthaffairs.org/do/10.1377/forefront.20220513.923426/
- 14 Information Blocking Claims. By the Numbers | HealthIT.gov. Accessed July 13, 2022 at: https://www.healthit.gov/data/quickstats/information-blocking-claims-numbers
- 15 Gerber DE. 21st century cures act: implementation without understanding implication?. JCO Oncol Pract 2022; 18 (02) 85-87
- 16 Winget M, Haji-Sheikhi F, Brown-Johnson C. et al. Electronic release of pathology and radiology results to patients: opinions and experiences of oncologists. J Oncol Pract 2016; 12 (08) e792-e799
- 17 Giardina TD, Callen J, Georgiou A. et al. Releasing test results directly to patients: a multisite survey of physician perspectives. Patient Educ Couns 2015; 98 (06) 788-796
- 18 Walker J, Leveille S, Bell S. et al. Opennotes after 7 years: patient experiences with ongoing access to their clinicians' outpatient visit notes. J Med Internet Res 2019; 21 (05) e13876
- 19 Nouri SS, Adler-Milstein J, Thao C. et al. Patient characteristics associated with objective measures of digital health tool use in the United States: a literature review. J Am Med Inform Assoc 2020; 27 (05) 834-841
- 20 Giardina TD, Baldwin J, Nystrom DT, Sittig DF, Singh H. Patient perceptions of receiving test results via online portals: a mixed-methods study. J Am Med Inform Assoc 2018; 25 (04) 440-446
- 21 Turer RW, Martin KR, Courtney DM. et al. Real-time patient portal use among emergency department patients since implementation of the 21st Century Cures Act: an open results study. Appl Clin Inform 2022; 13 (05) 1123-1130
- 22 Arvisais-Anhalt S, Lau M, Lehmann CU. et al. The 21st century cures act and multiuser electronic health record access: potential pitfalls of information release. J Med Internet Res 2022; 24 (02) e34085
- 23 Lyles CR, Wachter RM, Sarkar U. Focusing on digital health equity. JAMA 2021; 326 (18) 1795-1796
- 24 Tuan WJ, Mellott M, Arndt BG, Jones J, Simpson AN. Disparities in use of patient portals among adults in family medicine. J Am Board Fam Med 2022; 35 (03) 559-569
- 25 Steitz BD, Sulieman L, Wright A, Rosenbloom ST. Association of immediate release of test results to patients with implications for clinical workflow. JAMA Netw Open 2021; 4 (10) e2129553
- 26 Implementing Team-Cased Care to Increase Practice Efficiency. Accessed Oct 24, 2022 at: https://www.pbgh.org/wp-content/uploads/2020/12/implementing-team_based_care_ama_2017.pdf
- 27 ONC's Cures Act Final Rule. Accessed July 13, 2022 at: https://www.healthit.gov/curesrule/overview/about-oncs-cures-act-final-rule
- 28 How Medical Devices Work with mHealth Apps | HealthTech. Accessed August 01, 2022 at: https://healthtechmagazine.net/article/2022/06/how-medical-devices-work-with-mhealth-apps-perfcon
- 29 HLTH 2021: Meet the Patients Where They Are in the Continuously Transforming Digital Health Sphere. HealthTech Magazine. Accessed August 01, 2022at: https://healthtechmagazine.net/article/2021/10/hlth-2021-meet-patients-where-they-are-continuously-transforming-digital-health-sphere
- 30 Pérez-Stable EJ, Jean-Francois B, Aklin CF. Leveraging advances in technology to promote health equity. Med Care 2019; 57 (suppl 6 suppl 2): S101-S103
- 31 HealthITbuzz. Key Themes from HITAC Hearing on Health Equity by Design - Health IT Buzz. Accessed October 24, 2022 at: https://www.healthit.gov/buzz-blog/health-information-technology-advisory-committee/key-themes-from-hitac-hearing-on-health-equity-by-design
- 32 Kentucky HB529 AN ACT relating to the disclosure of laboratory test results and declaring an emergency. Accessed August 04, 2022 at: https://trackbill.com/bill/kentucky-house-bill-529-an-act-relating-to-the-disclosure-of-laboratory-test-results-and-declaring-an-emergency/2229787/
- 33 Bill Analysis - SB-1419 Health information. Accessed October 27, 2022 at: https://leginfo.legislature.ca.gov/faces/billAnalysisClient.xhtml?bill_id=202120220SB1419#
- 34 Perzynski AT, Roach MJ, Shick S. et al. Patient portals and broadband internet inequality. J Am Med Inform Assoc 2017; 24 (05) 927-932
- 35 Turer RW, DesRoches CM, Salmi L, Helmer T, Rosenbloom ST. Patient perceptions of receiving COVID-19 test results via an online patient portal: an open results survey. Appl Clin Inform 2021; 12 (04) 954-959