Overcoming EHR Adoption Challenges: Legal, Clinical, and Patient Perspectives

1. Chapter 3 Challenges of EHR Adoption

2. Reality Early designs were limited but efforts have overcome their limitations Data entry may really take longer, but there are real downstream time savings Establish expectations and metrics and measure benefits Most legal issues are waning Perception EHRs have design limitations Data entry takes longer in EHR than paper Cost is prohibitive There are legal issues with EHRs Nature of Challenge

3. Legal Issues • Even as legal concerns are being addressed to improve the flow of information while still providing for confidentiality and privacy, we must be aware of concerns of both providers and patients

4. Legal Issues: Sources of Law • Primary source: State law • with federal input becoming more common • Secondary source: Case law • Legal precedent is created by judges rather than legislatures. • In case law, judges can either interpret statutory law or common law.

5. Legal Issues: Authentication • Electronic signatures as a legal form • Most states have applied existing business rules, while some states have enacted new laws. • Federal law (HIPAA - 1996): addresses PHI in an electronic environment, including access controls and authentication • Federal law (MMA - 2003): e-prescribing (although DEA must still weigh in on controlled substances) • Federal law (E-SIGN): The Federal Electronic Signatures in Global and National Commerce Act of 2000 • Uniform Electronic Transactions Act, approved in July 1999 • FDA Regulations, 21 CFR Part 11 (1997)provides criteria for acceptance of electronic records and signatures • The Joint Commission: Standards safeguarding records and information • CMS: Medicare Conditions of Participation address maintenance of the health record

6. Forms of Signature in EHR • Intent is to replicate the strength of a “wet signature” (pen on paper) • Digitized signature: • Electronic signature: • Digital signature: Cryptographic signature that positively authenticates the user, and can provide nonrepudiation and message integrity

7. Retention and durability Storage Signature Accuracy of entries Transmission integrity Admissibility Evidence Discoverability Common thread: Records are retained as they were created and are not altered Custodian of records must be able to testify that the record was compiled in the normal course of business Legality of Records Issues

8. E-Discovery • Amendments to Federal Rules of Civil Procedure and Uniform Rules Relating to Discovery of Electronically Stored Information • Enable motion for court to order EHR’s metadata (data about data), such as: • Audit trail information • Decision support rules • Clinical practice guidelines • Other information not typically defined as the “legal health record”

9. In hospital: Physicians often have less “say” Some physicians may be less frequent users Process improvements and workflow changes need to address physician concerns, not just hospital worker issues In office: Physicians are primary decision maker, except potentially in a large practice Other clinicians will also use EHR and often are not included in decision making Administrative processes cannot be negatively impacted Overcoming Clinician Resistance

10. Clinician Involvement • Seek active involvement of all types of clinicians and create teams that are both focused and cross-cutting • Recognize that time is perhaps the most precious commodity any clinician owns. Use it wisely and plan for an EHR that saves time • Emphasize downstream time savings where data entry may take longer • Engage sufficient numbers of clinicians so that all points of view are represented (the inherent educational process is also spread to all) • (Cautiously) compensate clinicians for their participation, but not for use

11. Gaining Acceptance of Change • Effective management of change requires some hard questions to be asked and answered: • Is there an environment of readiness for change? • Education and set realistic expectations • Is there a clear vision and migration path established? • Is the vision limited to just a few “pain points” or to the full scope of what is feasible • Have realistic expectations been established? • Benefits must be measurable • Have sufficient funds been committed? • Access to workstations must be ubiquitous • Systems that go down frequently are unacceptable

12. Patient/Consumer Issues • Many patients understand and desire the efficiencies associated with the adoption of an EHR, but have issues with some aspects of automation of their information: • Privacy • Confidentiality • Consent management • Security • Identity theft • Quality of information

13. Patient Concerns Source: America’s Health Insurance Plans, July/August 2005.

14. Business Challenges • Healthcare is a business and faces many business-related challenges for EHR implementation. • Economic issues • Reduced reimbursement • Staffing shortages • Escalating costs for all aspects of operations • Limited access to capital

15. Addressing Business Challenges • Technological advances are making EHR systems more cost-effective • Although lower cost of technology is often offset by greater complexity of systems • Vendors realize they must meet time and budget commitments • CCHIT certification has helped • Providers are finding innovative ways to fund EHR systems, including outsourcing, grants, HIE participation, and incentives

16. Leadership and Change • Exemplary EHR implementations display the following characteristics of their executive leadership: • Significant involvement • Strategic imperative • Not just financial return on investment • Value proposition is important • Continuity of leadership • Commitment not to automate what is not working in manual environment • Customer service and end-user orientation

17. Nationwide Health Information Network • Individual provider leadership is essential for successful EHR implementation within an organization • Federal leadership has been provided to address overall health of nation: • Growing federal initiatives and support • Private sector initiatives for standards setting • State-led initiatives • NHIN is a concept. Will it meet the challenge?

18. Conclusion • Adoption (not just implementation) of EHR faces many challenges • Some are real and some are perceived (often lingering from a time when certain issues were more real) • New issues may be arising, especially in the area of privacy and security; and as more consumers become engaged • Many challenges are being overcome by clinician and patient engagement