All Hands Electronic Information Integrity Call White Paper An Introduction to the Current State of EMR – et.al. R. L. Chamberlain, Ph.D.

All Hands Electronic Information Integrity Call Current Activities Numerous – hundreds (1,300) – of companies selling systems They argue they do not need regulating Several sets of Regulations FDA – if used for a Clinical Trial HIPAA – If information is Private Sarbanes- Oxley – If used for Insurance Payments Others? When asked about someone with regulatory or compliance experience within their organization, they responded that “we do not currently have a need in those areas”. Compliance is the User’s Responsibility 2

All Hands Electronic Information Integrity Call EMR – EHR - Wellness Electronic Medical Record Systems (EMR) contains the standard medical and clinical data gathered in one provider’s office. Electronic Health Records Systems (EHR) go beyond the data collected in the provider’s office and include a more comprehensive patient history. Wellness Systems are typically owned by the patient. It has access to all of their EMR and EHR information but it also contains information indicating the “Wellness” of the patient. 3

All Hands Electronic Information Integrity Call History Interoperability Be able to access the different Medical Records – Primary Physician, Hospitals, Diagnostic, Laboratory. Other. Using CDISC. Developer Code of Conduct Electronic Medical Records Association (EMRA) has developed a Developer Code of Conduct that its members agree to – approx 80 Developers. Unique Patient Identifier there is no agreement for a Unique Patient Identifier between all of these systems. Apparently, there are some privacy or other issues. 4

All Hands Electronic Information Integrity Call The Food and Drug Administration Safety and Innovation Act (FDASIA). Author is HEALTHIT made up of several Agencies. Trying to Respond to Regulate or Not Regulate Three types of data Administrative – No accuracy issues Medical – Being covered by current activities Device – Must be Regulated RLC sees a potential Problem – Submitted as comment Importance of the data can change. Implement 3 different fields One field with 3 different characteristics Treat everything as worst case – Everything is a Device 5

All Hands Electronic Information Integrity Call Typical Installation Today Time Change Management Vendor Develop the System Specifications Programming Standards Testing Release User Interact with Patient Instruments (Not considered part of the system) _ _ _ _ _ _ _ _ Access the System Vendor Development SystemHospital Application System Install Train Update Procedures Vendor InfrastructureHospital Infrastructure Qualify the Infrastructure Interoperability Other Hospitals and Clinics 6

All Hands Electronic Information Integrity Call Players Vendors and Hospital IT Department The “Staffs” The Devices The Regulators The Lawyers and Insurance 7

All Hands Electronic Information Integrity Call Vendors and Hospital IT Department Implement QMS as in ISO 9000 Some claim to be doing it already Is not Regulation Lots of experience Developer Code of Conduct states it will be done Different QMS for each test? Don’t tell anyone, but if done properly they will almost Satisfy Regulations 8

All Hands Electronic Information Integrity Call The “Staffs” Need to Cover HealthCare from the time the “Patient Walks in the Door” 85% to 95% of the Cost is determined before the Observation is Entered. 85% to 95% of the Quality is determined before the Observation is Entered. Need written, usage, SOPs That are followed. 9

All Hands Electronic Information Integrity Call The Devices Need SOPs on the usage Sources already exist to make this EASY Hospital Lab is probably GLP compliant Manufacturer of the device could provide help Look to GLPs 10

All Hands Electronic Information Integrity Call The Regulators Set up a Small but elite group to represent the Regulations involved. Be prepared to meet with the Preceding group to discuss GAPs. Work out what ever is necessary New Regulations Guidances Training ?? 11

All Hands Electronic Information Integrity Call The Lawyers and Insurance Waiting to see? 12

All Hands Electronic Information Integrity Call Players Vendors and Hospital IT Department The “Staffs” Implement QMS as in ISO 9000 The Devices Look to their labs and device manufacturers for Accuracy Procedures Look at GLPs The Regulators After QMS is Implemented develop a GAP Analysis with regulations Address Gaps The Lawyers and Insurance ??? 13

All Hands Electronic Information Integrity Call Where is it Going?? Lots more Groups, Suggestions, Alternatives One Scenario “No Regulations” will Win. Will be serious Problems and Deaths Lawyers will get involved and Approach Congress. Congress will Require Regulations 14

All Hands Electronic Information Integrity Call Questions 15