From the Office of National Coordinator of Health Information Technology (ONC HIT):
“On June 18, the Office of the National Coordinator for Health Information Technology issued its temporary certification program final rule, which establishes a way for organizations to become authorized by the National Coordinator to test and certify electronic health record technology.”
To read more information and to read the rule, click here.
On May 13, 2010, the United States District Court for the Southern District of New York rejected the privacy challenge to the Health Information Technology for Economic and Clinical Health Act (HITECH Act) asserted by Beatrice M. Heghmann, a registered nurse, and Robert A. Heghmann, her husband and attorney, against Kathleen Sebelius, Secretary of the Health & Human Services (HHS), Nancy-Ann DeParle, Director, White House Office of Health Reform, and Charlene Frizzera, Administrator, Centers For Medicare and Medicaid Services (CMS). The Plaintiffs alleged that HITECH violates the HIPAA Privacy Rule, the Privacy Act, and Federal Common Law.
Update 9/24/2020: In the 10 years since we wrote this article, the DEA received questions and requests for clarification on various issues concerning the implementation and technical requirements for e-prescribing controlled substances. To provide further clarification, this year, the DEA reopened the EPCS Interim Final Rule for additional comments. The DEA also noted that it anticipated issuing a final rule on the topic of EPCS. The additional comments period closed on June 22, 2020.
On March 31, 2010, the Drug Enforcement Agency (DEA) published its Interim Final Rule (IFR) addressing electronic prescriptions (e-prescribing) for controlled substances, 75 Federal Register 16236 (effective June 1, 2010). Prior to this, the DEA had been concerned that the lack of security controls for e-prescribing of controlled substances would lead to higher levels of illegal use. That concern, along with the rigid requirements of the Controlled Substances Act of 1970 (CSA), had been a barrier for DEA in moving forward with its e-prescribing rule, which was originally proposed in June 2008. The DEA’s IFR cites the passage of the Health Information Technology for Economic and Clinical Health (HITECH) Act, which was part of the American Recovery and Reinvestment Act of 2009 (ARRA), and HITECH’s encouragement of e-prescribing, as one impetus for propelling this issue forward. DEA also indicated that the lack of a mature standard that allows for electronic interoperability (i.e. formatting of prescription data) among e-prescribing applications (e.g., from physician to pharmacy) was another reason to forge ahead and fill the gap.
On March 24, 2010, the U.S. Department of Health & Human Services (HHS) posted a 30-day notice to solicit comments under the Paperwork Reduction Act of 1995 regarding its estimate of the burden to conduct a survey about public attitudes towards an electronic health information exchange and the associated privacy and security aspects. The Office of the National Coordinator for Health Information Technology (ONC) would conduct the nationwide survey using computer assisted telephone interviews to interview a representative sample of the U.S. population. An estimated 25,415 households would be contacted out of which HHS estimates that 2,570 households will respond. The data collection, to take place over the course of eight weeks, would solicit information “about individuals’ attitudes toward electronic health information exchange and the extent to which they are interested in determining by whom and how their health information is exchanged.” HHS says, “The proposed information collection will permit us to better understand individuals’ attitudes toward electronic health information exchange and its associated privacy and security aspects as well as inform policy and programmatic objectives.”
Before the publication of the final report, ONC will host a Web seminar to convey findings to the general public. A final report will be posted on http://healthit.hhs.gov and will include the results and analysis of the survey.
On March 2, 2010, the Office of National Coordinator (ONC) issued its proposed rulemaking respecting the certification standards that an eligible health care provider’s electronic health record must satisfy in order to qualify for incentives under the Health Information Technology for Clinical and Economic Health Act (HITECH Act), which was part of the American Recovery and Reinvestment Act of 2009 (ARRA). The ONC proposes establishing two certification programs:
1) A temporary certification program whereby the ONC would authorize organizations to test and certify Complete EHRs and/or EHR Modules, thereby assuring the availability of Certified EHR Technology prior to the date on which health care providers seeking the incentive payments may begin demonstrating meaningful use of Certified EHR Technology; and
2) A permanent certification program that would replace the temporary certification program. The permanent certification program would separate the responsibilities for performing testing and certification, introduce accreditation requirements, establish requirements for certification bodies authorized by the ONC related to the surveillance of Certified EHR Technology, and would include the potential for certification bodies authorized by the ONC to certify other types of health information technology besides Complete EHRs and EHR Modules.
The comment period for the proposed rule will be established once it is published in the Federal Register. In the meantime, you can read the proposed rule on the ONC’s webpage.
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