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© 2015 Health Level Seven ® International. All Rights Reserved.

HL7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U.S. TM Office.

EHR Records Risk Assessments

An Evolving Use of the EHR System

Functional Model Standard

HIMSS HL7

April 15, 2015

Reed D. Gelzer, MD, MPH

Co-Chair, HL7 EHR Workgroup

Co-Faciltator, HL7 EHR Records Management

and Evidentiary Support Workgroup

and HL7 EHR/Security Vocabulary Alignment Workgroup

Provider Resources, Inc.

(2)

© 2015 Health Level Seven ® International. All Rights Reserved.

HL7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U.S. TM Office.

Overview

EHR-S FM R2: Normative Standard

“The HL7 EHR-S Functional Model defines a

standardized model of the functions that may be

present in EHR Systems.”

01/01/2011

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© 2015 Health Level Seven ® International. All Rights Reserved.

HL7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U.S. TM Office.

Overview

What is Records Risk?

What does Records Risk look like?

How does the EHR-S FM R2 (aka R2) help?

01/01/2011

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© 2015 Health Level Seven ® International. All Rights Reserved.

HL7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U.S. TM Office.

Records Risk

Records:

Representations of acts and events in the real world

Risks to their value as accurate representations:

Reliable means of origination

Security

Authenticity

Persistence

01/01/2011

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© 2015 Health Level Seven ® International. All Rights Reserved.

HL7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U.S. TM Office.

5

Origination Risk

A group of

inexperienced and

uncertified

inspectors for the

Department of

Licenses and

Inspection conducted

around 600

inspections of unsafe

buildings in a single

week last month, the

Inquirer has learned.

Each of the newly

hired inspectors then

recorded their work

in L&I’s database

under the name of

another man, an

experienced

inspector with the

agency.

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© 2015 Health Level Seven ® International. All Rights Reserved.

HL7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U.S. TM Office.

Origination Risk

01/01/2011

(7)

© 2015 Health Level Seven ® International. All Rights Reserved.

HL7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U.S. TM Office.

(8)

© 2015 Health Level Seven ® International. All Rights Reserved.

HL7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U.S. TM Office.

Recommendation:

Release of Information (ROI)

Risk Assessment

Evaluating:

1. Authorship

2. Log (“Audit”) functions

3. Amendments

EHR Systems:

Systems of Systems

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© 2015 Health Level Seven ® International. All Rights Reserved.

HL7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U.S. TM Office.

Origination For Authenticity

Recommendation:

Release of Information (ROI) Risk Assessment

Examples:

Records releases for business or clinical requests

(legal process or claims support/revenue integrity)

Data extracts to support Quality measures

Transitions of Care Support

01/01/2011

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© 2015 Health Level Seven ® International. All Rights Reserved.

HL7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U.S. TM Office.

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© 2015 Health Level Seven ® International. All Rights Reserved.

(12)

© 2015 Health Level Seven ® International. All Rights Reserved.

HL7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U.S. TM Office.

R2 Checklist: Originate & Retain

01/01/2011

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© 2015 Health Level Seven ® International. All Rights Reserved.

HL7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U.S. TM Office.

R2 Checklist: Originate & Retain

01/01/2011

14

1. The system SHALL provide the ability to capture

(originate) a Record Entry instance corresponding to

an Action instance and context

.

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© 2015 Health Level Seven ® International. All Rights Reserved.

HL7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U.S. TM Office.

Checklist: Evidence of Originate

& Retain

01/01/2011

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© 2015 Health Level Seven ® International. All Rights Reserved.

HL7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U.S. TM Office.

Know Your Objectives

Risk Identification: Keep it simple and practical

Risk Mitigation Mapping

-Training?

-Configuration?

-Design?

01/01/2011

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© 2015 Health Level Seven ® International. All Rights Reserved.

HL7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U.S. TM Office.

Objectives

Risk Mitigation: Keep it actionable

Medical Staff Bylaws (Hospitals)

Medical Records P&P

EHR FM R2-Derived Due-Diligence

Templates

01/01/2011

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© 2015 Health Level Seven ® International. All Rights Reserved.

HL7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U.S. TM Office.

Notables…

HIMSS presentation slides for “Medical-Legal

Cases That Went South” by Dr. Keith Klein

“Electronic Health Records Systems: Testing

The Limits of Digital Records’ Reliability and

Trust” in Ave Maria Law Review, Summer 2014

by Drury, Gelzer, Trites, and Paul.

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© 2015 Health Level Seven ® International. All Rights Reserved.

HL7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U.S. TM Office.

Questions

Reed D. Gelzer, MD, MPH

[email protected]

www.Provider-Resources.com

Co-Chair, HL7 EHR Standards Workgroup

Co-Facilitator, HL7 Records Management and

Evidentiary Support Workgroup

Trustworthy EHR, LLC

Newbury, NH

Philadelphia, PA

203-506-5361

References

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