comp5 unit11 lecture slides

History of Health Information Technology in the U.S.

Software Certification and Regulation

This material Comp5_Unit11 was developed by The University of Alabama Birmingham, funded by the Department of Health and Human Services, Office of the National Coordinator for Health Information Technology under Award Number

1U24OC000023

Software Certification and RegulationLearning Objectives

2

• 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 recent efforts to improve the safety of EHRs

Health IT Workforce Curriculum Version 3.0/Spring 2012

History of Health Information Technology in the U.S. Software Certification and

Regulation

Certification and Regulation

Food and Drug Administration (FDA)



Regulation3


• Certification– Functionality– Individual EHRs

4Health IT Workforce Curriculum Version 3.0/Spring 2012


Regulation


• Certification– Functionality– Individual EHRs

• FDA Center for Devices and Radiological Health (CDRH)– Embedded software– Accessory software for regulated device– Stand-alone software



Regulation


• Pre-market Review– Design– Manufacturing practices– Testing

• Post-market Review– Problems



Regulation


• Challenges– Difficult to test in advance– Interaction with other systems– Problems have multiple causes



Regulation


• Challenges– Difficult to test in advance– Interaction with other systems– Problems have multiple causes

• Does not guarantee– Safe implementation– Usability– Outcomes



Regulation

Early Attempts at Regulation• Principle of ‘competent human intervention’

(learned intermediary)• FDA draft rule – 1989



Regulation

Source: (Manning, 1996)

Early Attempts at Regulation

FDA Workshop – 1996• Stand-alone software systems

– Clinical decision support– Closed and open loop systems

• Recommendations– Risk Classification– Software Quality Audits

Source: (Manning, 1996)



Regulation

1997 Professional Organization Recommendations

• Articles published in two journals– JAMIA for informatics professionals– Annals of Internal Medicine for physicians and

health professionals

Sources: (Miller & Gardner, JAMIA, 1997)(Miller & Gardner, Ann Intern Med, 1997)



Regulation

1997 Professional Organization Recommendations

• Articles published in two journals– JAMIA for informatics professionals– Annals of Internal Medicine for physicians and

health professionals• FDA focus should be:

– High risk systems – Systems with limited opportunity for

competent human intervention– Good manufacturing/design practices– Software monitoring at local level



Regulation

1999 — Institute of Medicine Report

• To Err is Human• Focus on Patient

Safety• Information

Technology as mechanism to IMPROVE safety



Regulation

Photo by Nir Menachemi

Growing Interest in Health Information Technology

• Additional Institute of Medicine reports– Crossing the Quality Chasm – 2001– Patient Safety – 2004– Preventing Medication Errors – 2006

Source: (Quality Chasm Series, 2001)



Regulation

Growing Interest in Health Information Technology


• Leapfrog Group – 2000– CPOE to reduce medication errors



Regulation

Growing Interest in HealthInformation Technology


• Leapfrog Group – 2000– CPOE to reduce medication errors

• Office of the National Coordinator – 2004• Certification Commission for Health

Information Technology (CCHIT) – 2004



Regulation

Certification Commission for Health Information Technology

• Non-profit private organization• Formed by three bodies representing the IT

community in 2004– AHIMA, HIMSS, and NAHIT



Regulation

Certification Commission for Health Information Technology

• Non-profit private organization• Formed by three bodies representing the IT

community in 2004– AHIMA, HIMSS, and NAHIT

• Contract to develop criteria – 2006• EHR certification body – 2006

– Single systems– Inpatient and outpatient



Regulation

Research, HIT, and Patient Safety• Research directions

– HIT can improve patient safety• CPOE• Clinical Decision Support



Regulation

Research, HIT, and Patient Safety• Research directions

– HIT can improve patient safety• CPOE• Clinical Decision Support

– HIT can cause unintended consequences• Ash and colleagues

– CPOE and negative reactions– Other problems

• Koppel and colleagues– JAMA – 2005– Safety concerns

Sources: (Ash, et al., 2009)(Koppel, et al., 2005)



Regulation

HITECH Act

• 2009• Incentives for meaningful use of EHRs• Anticipate increase in EHR adoption• Certifying bodies for EHRs



Regulation

HITECH Act

• 2009• Incentives for meaningful use of EHRs• Anticipate increase in EHR adoption• Certifying bodies for EHRs• Increased concern about safety and

need for regulation– Congressional hearings– FDA reviewing policies



Regulation

ONC Authorized Testing and Certification Bodies

• Organizations apply to ONC to become certification bodies– 2010—ATCBs– 2012—ATLs and ACBs

• Separate testing and certification



Regulation

Institute of Medicine Consensus Study

• Plan to study risks of health IT and make recommendations on risk management

• Greater transparency

Source: (Institute of Medicine, 2011)


History of Health Information Technology in the U.S. Software Certification

and Regulation24

Courtesy National Academies Press

Institute of Medicine Consensus Study

• Plan to study risks of health IT and make recommendations on risk management

• Greater transparency• Criteria to assess and monitor safe use of

health IT• Public reporting of adverse events• Agency to investigate serious problems• If insufficient progress, FDA may regulate• More research on better designsHealth IT Workforce Curriculum Version 3.0/Spring 2012

History of Health Information Technology in the U.S. Software Certification

and Regulation25

Usability and Certification• NIST

– Usability guidelines• 2014 certification criteria

– Safety-enhanced design• User-centered design

– CPOE, CDSS, e-prescribing– Drug-drug, drug-allergy checks– Medication and medication allergy lists– Electronic medication administration record– Clinical information reconciliation

• Attention to quality management principles



Regulation26

Pros and Cons of Regulation• Pro: Protect patient and purchaser• Con: Stifle innovation



Regulation

Courtesy US Army. Photographer: Sgt. Jon Soles, MND-B PAO

Software Certification and RegulationSummary

• History of FDA involvement• EHR certification• Changes with HITECH Act• IOM report on health IT and patient safety



Regulation

Software Certification and RegulationReferences

References• Ash JS, Sittig DF, Dykstra R, Campbell E, Guappone K. The unintended consequences of computerized provider

order entry: findings from a mixed methods exploration. Int J Med Inform. 2009 Apr;78 Suppl 1:S69-76.• Institute of Medicine. Health IT and Patient Safety: Building Safer Systems for Better Care. Washington (DC): The

National Academies Press, 2011.• Koppel R, Metlay JP, Cohen A, Abaluck B, Localio AR, Kimmel SE, Strom BL. Role of computerized physician

order entry systems in facilitating medication errors. JAMA. 2005 Mar 9;293(10):1197-203.• Manning W. Summary of Food and Drug Administration & National Library of Medicine Software Policy Workshop,

Sept. 3-4, 1996. The Health Law Resource. Available from: http://www.netreach.net/~wmanning/fdaswsem.htm• 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;4(6):442-57.

• Miller RA, Gardner RM. Summary recommendations for responsible monitoring and regulation of clinical software systems. American Medical Informatics Association, The Computer-based Patient Record Institute, The Medical Library Association, The Association of Academic Health Science Libraries, The American Health Information Management Association, and The American Nurses Association. Ann Intern Med. 1997;127(9):842-5.

• Quality Chasm Series: Health Care Quality Reports from the Institute of Medicine. Washington DC: The National Academies Press. 2001. Available from: http://www.nap.edu/catalog.php?record_id=12610



Regulation

http://www.netreach.net/~wmanning/fdaswsem.htm



Software Certification and RegulationReferences

ImagesSlide 9: Microsoft clip art; Used with permission from Microsoft.Slide 13: Nir Menachemi. Kohn LT, Corrigan JM and Donaldson MS, (eds). To Err Is Human: Building a Safer Health

System Committee on Quality of Health Care in America, Institute of Medicine, Washington DC: National Academies Press, 1999. Image used with permission from National Academies Press.

Slide 24: Nir Menachemi. 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 Academies Press, 2011. Image used with permission from National Academies Press.

Slide 27: Sgt. Jon Soles, MND-B PAO. Available from: http://www.army.mil/media/73855. Photo courtesy of U.S. Army.



Regulation

http://www.army.mil/media/73855

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