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Meaningful Use and Certification of Health Information Technology: What about Safety?

Published online by Cambridge University Press:  01 January 2021

Extract

Health information technology (HIT) is becoming increasingly prevalent in medical offices and facilities. Like President George W. Bush before him, President Obama announced a plan to computerize all Americans’ medical records by 2014. Computerization is certain to transform American health care, but to ensure that its benefits outweigh its risks, the federal government must provide appropriate oversight.

President Obama’s stimulus legislation, the American Recovery and Reinvestment Act of 2009 (ARRA), dedicated $27 billion to the promotion of health information technology. It provides payments of up to $44,000 per clinician under the Medicare incentive program and $63,750 per clinician under the Medicaid program.

Type
JLME Supplement
Copyright
Copyright © American Society of Law, Medicine and Ethics 2011

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References

American Recovery and Reinvestment Act of 2009, Pub. L. No. 5, §§ 4101–4102, 123 Stat. 115 (2009).Google Scholar
Establishment of the Temporary Certification Program for Health Information Technology; Final Rule, 45 C.F.R. §§170.400–170.499 (2010); Health Information Technology: Initial Set of Standards, Implementation Specifications, and Certification Criteria for Electronic Health Record Technology, 45 C.F.R. §§ 170.102–170.306; Final Rule Medicare and Medicaid Programs; Electronic Health Record Incentive Program 42 C.F.R. Parts 412, 413, 422, 495 (2010).Google Scholar
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45 C.F.R. §§ 170.302(o)-(w), 170.304(i) andl70.306(f) (2010).CrossRefGoogle Scholar
45 C.F.R. §§ 170.400–170.499 (2010).CrossRefGoogle Scholar
See Healthcare Information and Management Systems Society (HIMSS), Frequently Asked Questions on Establishment of the Temporary Certification Program for Health Information Technology Final Rule, June 21, 2010, available at <http://www.himss.org/content/files/HHS_TempCertification_FAQs.pdf> (last visited December 13, 2010).+(last+visited+December+13,+2010).>Google Scholar
45 C.F.R. § 170.423(a), (e) (2010). HHS will likely rely largely on testing tools developed by the National Institute of Standards and Technology (NIST). Department of Health and Human Services, “Establishment of the Temporary Certification Program for Health Information Technology,” Federal Register 75 (June 24, 2010): 36158, 36168Google Scholar
45 C.F.R. § 170.490 (2010).Google Scholar
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Schulte, F. and Schwartz, E., “FDA, Obama Digital Medical Records Team at Odds over Safety Oversight,” Huffington Post, August 3, 2010, available at <http://huffpostfund.org/stories/2010/08/fda-obama-digital-medical-records-team-odds-over-safety-oversight> (last visited December 13, 2010). These incidents involved systems produced by Cerner Corp. The company claimed that the medication delivery problem was associated with “technician error” and that “the mixing up of patients was the result of a ‘Cerner coding issue’ involving software that occurred after an upgrade.”+(last+visited+December+13,+2010).+These+incidents+involved+systems+produced+by+Cerner+Corp.+The+company+claimed+that+the+medication+delivery+problem+was+associated+with+“technician+error”+and+that+“the+mixing+up+of+patients+was+the+result+of+a+‘Cerner+coding+issue’+involving+software+that+occurred+after+an+upgrade.”>Google Scholar
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See Hoffman, and Podgurski, , supra note 3, at 145–150.Google Scholar
45 C.F.R. §170.423 (2010). ATCBs are required to operate according to the International Organization for Standardization's general requirements for competence of testing and calibration laboratories (ISO/IEC 17025) and requirements for bodies operating product certification systems (ISO/IEC GUIDE 65).Google Scholar
See Han, Y. Y., Carrillo, J. A., Venkataraman, S. T., Clark, R. S. B., Watson, R. S., Nguyen, T. C., Bayir, H., and Orr, R. A., “Unexpected Increased Mortality after Implementation of a Commercially Sold Computerized Physician Order Entry System,” Pediatrics 116 (2005): 15061512. The researchers found an increase in mortality after CPOE was implemented at a children's hospital (from 2.80% to 6.57%).CrossRefGoogle Scholar
See Certification Commission for Health Information Technology (CCHIT), available at <http://www.cchit.org/> (last visited December 13, 2010). CCHIT was among the first entities to be approved as an ATCB. See U.S. Department of Health & Human Services, Initial EHR Certification Bodies Named, Press Release, August 30, 2010, available at <http://www.hhs.gov/news/press/2010pres/08/20100830d.html> (last visited December 13, 2010).+(last+visited+December+13,+2010).+CCHIT+was+among+the+first+entities+to+be+approved+as+an+ATCB.+See+U.S.+Department+of+Health+&+Human+Services,+Initial+EHR+Certification+Bodies+Named,+Press+Release,+August+30,+2010,+available+at++(last+visited+December+13,+2010).>Google Scholar
For a critique of FDA oversight, see Hoffman, and Podgurski, , supra note 3, at 134–138.Google Scholar
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