Component 5; Unit 11: Software Certification and Regulation
Description:
This unit describes the history of software certification and regulation.
Objectives:
- Discuss the history of FDA involvement in the regulation of clinical software.
- Describe the origins, focus and activities of CCHIT.
- Discuss the changes in the EHR certification process as a result of the HITECH Act.
- Discuss the efforts to improve the safety of EHRs.
Component 5; Unit 11; Lecture 11 comp5_unit11_lecture_slides :
Software Certification and Regulation (28:01:) 1) Explanation of EHR certification and FDA regulation processes; 2) Challenges in regulation of EHRs; 3) 1989 FDA policy on ‘competent human intervention’; 4) Recommendations on software regulation from 1996 FDA workshop; 5) Rise of interest in HIT-1999-2004; 6) 2004-2009 Certification of EHRs-origins and role of CCHIT; 7) Patient safety and HIT regulation; 8) HITECH requirements for certification of HIT ; 9) Evolution of certification requirements; 10) Unintended consequences of HIT; 11) Improving the Safety of HIT
Suggested Readings
Note: This reading addresses the history of FDA regulation. Additional materials for the topic of certification are in the section below on Additional Materials.
Miller RA, Gardner RM. Recommendations for responsible monitoring and regulation of clinical software systems. American Medical Informatics Association, Computer-based Patient Record Institute, Medical Library Association, Association of Academic Health Science Libraries, American Health Information Management Association, American Nurses Association. J Am Med Inform Assoc. 1997 Nov-Dec;4(6):442-57. Available from: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC61262/
Committee on Patient Safety and Health Information Technology. Board on Health Care Services.Health IT and Patient Safety: Building Safer Systems for Better Care, Washington, DC: National AcademiesPress, 2011. Free Executive Summary. Available from: http://books.nap.edu/openbook.php?record_id=13269
FDA, FCC, ONC. FDASIA Health IT Report. Proposed Strategy and Recommendations for the Risk-Based Framework. April, 2014. Available from:https://www.healthit.gov/sites/default/files/fdasia_healthitreport_final.pdf
Office of the National Coordinator for Health IT. ONC Health IT Safety Program – Progress on Health IT Patient Safety Action and Surveillance Plan. 2014. Available from: https://www.healthit.gov/sites/default/files/ONC_HIT_SafetyProgramReport_9-9-14_.pdf
Additional Materials
ONC Standards and Certification— This website is useful to monitor the changes in the certification process. It is available from: https://www.healthit.gov/policy-researchers-implementers/standards-and-certification-regulations