Hostname: page-component-848d4c4894-2pzkn Total loading time: 0 Render date: 2024-05-08T21:36:32.776Z Has data issue: false hasContentIssue false
  • English
  • Français

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

Published online by Cambridge University Press:  01 January 2021

Sharona Hoffman  and
Andy Podgurski
Get access Rights & Permissions [Opens in a new window]

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
Information
Journal of Law, Medicine & Ethics , Volume 39 , Issue S1 , Spring 2011 , pp. 77 - 80
Copyright
Copyright © American Society of Law, Medicine and Ethics 2011

Access options

Get access to the full version of this content by using one of the access options below. (Log in options will check for institutional or personal access. Content may require purchase if you do not have access.)

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
Hoffman, S. and Podgurski, A., “Finding a Cure: The Case for Regulation and Oversight of Electronic Health Record Systems,” Harvard Journal of Law and Technology 22, no. 1 (2008): 103–165 [hereinafter cited as Finding a Cure].Google Scholar
Hoffman, S. and Podgurski, A., “E-Health Hazards: Provider Liability and Electronic Health Record Systems,” Berkeley Technology Law Journal 24, no. 4 (2009): 1523–1581.Google Scholar
Centers for Medicare and Medicaid Services, Secretary Sebelius Announces Final Rules To Support ‘Meaningful Use’ of Electronic Health Records, Press Release, July 13, 2010, available at <https://www.cms.gov/apps/media/press/release.asp?Counter=3786&intNumPerPage=10&checkDate=&checkKey=&srchType=l&numDays=3500&srchOpt=0&srchData=&keywordType=All&chkNewsType=l%2C+2%2C+3%2C+4%2C+5&intPage=&showAll=&pYear=&year=&desc=&cboOrder=date> (last visited December 13, 2010) (hereinafter “Meaningful Use” Press Release).+(last+visited+December+13,+2010)+(hereinafter+“Meaningful+Use”+Press+Release).>Google Scholar
Blumenthal, D. and Tavenner, M., “The ‘Meaningful Use’ Regulation for Electronic Health Records,” New England Journal of Medicine 363, no. 6 (2010): 501–504.CrossRefGoogle Scholar
Id, at 502–03.Google Scholar
45 C.F.R. §§ 170.300–170.306 (2010).CrossRefGoogle Scholar
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
See “Meaningful Use” Press Release, supra note 5, at 504.Google Scholar
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
Singh, H., Mani, S., Espadas, D., Petersen, N, Franklin, V., and Petersen, L. A., “Prescription Errors and Outcomes Related to Inconsistent Information Transmitted through Computerized Order Entry,” Archives of Internal Medicine 169, no. 10 (2009): 982–989. The errors were “related to inconsistent information within the same prescription (i.e., mismatch between the structured template and the associated free-text field).”CrossRefGoogle Scholar
Walker, J., Carayon, P., Leveson, N., Paulus, R., Tooker, J., Chin, H., Bothe, A., and Stewart, W., “EHR Safety: The Way Forward to Safe and Effective Systems,” Journal of the American Medical Informatics Association 15 (2008): 272–277.CrossRefGoogle Scholar
See “Approved Test Procedures,” available at <http://health-care.nist.gov/use_testing/finalized_requirements.html> (last visited December 13, 2010).+(last+visited+December+13,+2010).>Google Scholar
See Hoffman, and Podgurski, , supra note 3, at 143–147.Google Scholar
Del Beccaro, M. A., Jeffries, H. E., Eisenberg, M. A., and Harry, E. D., “Computerized Provider Order Entry Implementation: No Association with Increased Mortality Rates in an Intensive Care Unit,” Pediatrics 118 (2006): 290–295. The authors found that “implementation issues (more order sets, sentences, code-set filtering, ability to get medications directly from the medication-dispensing system in emergent cases) rather than inherent issues with the CPOE itself or the underlying high risk of a particular software system are the primary risk factors affecting mortality during implementation of CPOE.”CrossRefGoogle Scholar
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): 1506–1512. 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