Presentation Transcript

1. Regulation of Electronic Health Record Systems: Implications for Software Engineering

   Andy Podgurski EECS Dept., Case Western Reserve Univ. Sharona Hoffman Case School of Law, CWRU
2. EHR systems Record systems Clinical alerts and reminders Decision aids Links to medical literature Computerized physician order entry Data analysis tools (enable searches) Interoperability
3. Support for EHR systems Pres. Bush 10 year initiative for NHIN State initiatives American Recovery and Reinvestment Act (ARRA): $19B+ Goal: computerize all health records by 2014
4. Potential benefits of EHR systems Reduce errors Improve patient safety Improve preventive care Facilitate communication Cost savings Facilitate research Promote evidence-based medicine and clinical practice guidelines
5. Risks of EHR systems Cost & burden of adoption Only 2.9% of U.S. hospitals have comprehensive EHR systems “across all major clinical units” Time investment Failures, downtime, usability problems Impact patient health and safety Privacy and security violations
6. Legal issues Liability of health care providers and EHR system vendors “Hold harmless” clauses in vendor contracts Faithfully recording medical activities and results can facilitate discovery of truth Proving failures of EHR systems Will use of decision support be a defense? Mining EHRs to establish standard of care
7. Federal regulation needed EHR systems currently certified by CCHIT Industry-based organization Testing lasts only 1 day; applicants are given testing scenarios; doesn’t address safety, reliability, usability EHR use covered by HIPAA Security Rule Specifications and enforcement inadequate Federal regulations don’t address safety and efficacy
8. Recent developments ARRA established Office of National Coordinator for HIT within HHS HITECH Act calls for “initial set of standards, implementation specifications, and certification criteria” by Dec. 31, 2009 No details provided Suggests adherence will be voluntary
9. Needed regulatory steps Establish EHR system approval and monitoring processes Field testing of new products for 6 months or more Utilize local “System Oversight Committees” Post-market monitoring Publication of adverse event reports
10. EHR system standards Best practices for development & operation Interoperability User-interface characteristics Authorization and access control Audit trails, capture-replay Decision support mechanisms
11. National research database De-identified EHRs stored in national database Accessible to researchers who apply to regulatory agency Would permit observational studies in which millions of EHRs are mined Would help fill knowledge gaps and promote evidence-based medicine
12. Software engineering challenges: safety, reliability, usability EHRs have pervasive influence on medical care System flaws can expose thousands of patients to safety risks Usability problems can also Downtime can paralyze hospital Cannot validate system independently of usage
13. SE challenge: interoperability Semantic interoperability required Medical terminology is vast, diverse, changeable, inconsistent Market disincentives exist for vendors Safety critical Privacy sensitive
14. SE challenge: controlling access Cannot deny caregivers necessary access Should prevent inappropriate access
15. SE challenge: designing EHR systems in tandem with clinical practices “Weaving” system design together with clinical practice guidelines Progressing from “standard of care” to “best known practices” Co-validating systems and practices
16. SE challenge: Summarizing relevant medical facts Many EHR systems overwhelm caregivers with irrelevant information Lifetime records will necessitate powerful summarization capabilities Omissions can be fatal e.g., drug allergy
17. Research obstacle: access to EHR systems Research on software engineering for EHR systems can’t succeed without it Hurdles to access: Privacy rules Liability Contracts Other priorities
18. Articles Finding A Cure: The Case for Regulation and Oversight of Electronic Health Record Systems Harvard Journal of Law & Technology, Vol. 22, No. 1, Fall 2008, jolt.law.harvard.edu/articles/pdf/v22/ 22HarvJLTech103.pdf In Sickness, Health, and Cyberspace: Protecting the Security of Electronic Private Health Information Boston College Law Review, Vol. 48, No. 2, March 2007, www.bc.edu/schools/law/ lawreviews/ bclawreview/Past_Issues/48_2/48_2.html