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

American Recovery and Reinvestment Act of 2009, Pub. L. No. 5, §§ 4101–4102, 123 Stat. 115 (2009).

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).

Hoffman S. 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].

Hoffman S. Podgurski A. , “E-Health Hazards: Provider Liability and Electronic Health Record Systems,” Berkeley Technology Law Journal 24, no. 4 (2009): 1523–1581.

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).

Blumenthal D. Tavenner M. , “The ‘Meaningful Use’ Regulation for Electronic Health Records,” New England Journal of Medicine 363, no. 6 (2010): 501–504.

Id, at 502–03.

45 C.F.R. §§ 170.300–170.306 (2010).

45 C.F.R. §§ 170.302(o)-(w), 170.304(i) andl70.306(f) (2010).

45 C.F.R. §§ 170.400–170.499 (2010).

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).

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, 36168

45 C.F.R. § 170.490 (2010).

See “Meaningful Use” Press Release, supra note 5, at 504.

Schulte F. 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.”

Singh H. Mani S. Espadas D. Petersen N Franklin V. 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).”

Walker J. Carayon P. Leveson N. Paulus R. Tooker J. Chin H. Bothe A. Stewart W. , “EHR Safety: The Way Forward to Safe and Effective Systems,” Journal of the American Medical Informatics Association 15 (2008): 272–277.

See “Approved Test Procedures,” available at <http://health-care.nist.gov/use_testing/finalized_requirements.html> (last visited December 13, 2010).

See Hoffman Podgurski , supra note 3, at 143–147.

Del Beccaro M. A. Jeffries H. E. Eisenberg M. A. 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.”

See Hoffman Podgurski , supra note 3, at 145–150.

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).

See Han Y. Y. Carrillo J. A. Venkataraman S. T. Clark R. S. B. Watson R. S. Nguyen T. C. Bayir H. 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%).

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).

For a critique of FDA oversight, see Hoffman Podgurski , supra note 3, at 134–138.