After a 3-year investment to achieve President Bush's mandate to create a national e-medical records system, the focus of the computerized health records discussions in Washington has shifted to privacy protections.
In his 2004 State of the Union address, President Bush challenged the nation to eliminate paper medical records within a decade. The president followed up with an Executive Order on April 27, 2004, that called for the widespread deployment of health information technology within 10 years.
Since then, there have been many Congressional hearings on the topic of computerized health records that focused on achieving the Bush administration's mandate to improve healthcare quality and reduce healthcare spending. But since Democrats took control in Washington nearly four months ago, lawmakers have focused more intently on the need for stronger privacy protections in any nationwide system of digital medical records.
Developments in 2007
On Feb. 1, 2007, Sen. Daniel Akaka chaired a Senate Homeland Security and Governmental Affairs subcommittee hearing on "Private Health Records: Privacy Implications of the Federal Government's Health Information Technology Initiative." The Government Accountability Office presented a report concluding that Health and Human Services (HHS) needs to create a stronger business plan for incorporating privacy and security milestones into its health information technology expansion plans.
Dr. Robert Kolodner, the HHS Interim National Coordinator for Health Information Technology, explained at the hearing that HHS will develop those milestones once it receives a baseline report on state privacy laws from the National Governors AssociationPrivacy Taskforce in the second quarter of 2007. Tennessee Gov. Phil Bredesen later explained to the Health Information and Management Systems Society (HIMSS) conference that:
"The [NGA's] Privacy Taskforce is now charged with looking at the major state health privacy laws with an eye to how they affect the ability to achieve a workable sharing of information. It is then charged with making recommendations as to how to address such issues. It will work with the Health Information Privacy and Security Collaboration that 33 states and Puerto Rico have begun. Every state has laws on the books that never envisioned interoperable health records, and we need to point the way to cleaning up this landscape."
Also at the Feb. 1 hearing, Mark Rothstein, a law professor who sits on an HHS advisory board, the National Committee for Vital and Health Statistics (NCVHS), warned that health information technology is launching without adequate built-in privacy and security standards. He complained that HHS Secretary Leavitt is not implementing the NCVHS privacy and security recommendations made in a June 22, 2006, NCVHS letter. Akaka appears interested in a legislative remedy, such as expanding the scope of the Health Insurance Portability and Accountability Act (HIPAA) Privacy and Security provisions.
Before the month was over, Paul Feldman, Deputy Director of the Health Privacy Project, resigned as co-chair of the American Health Information Community's (AHIC) confidentiality, privacy and security workgroup in protest of the group's allegedly slow pace. In response to this resignation, the chair of the House Ways and Means health subcommittee, Rep. Pete Stark, D-Calif., said in a written statement:
"The only way health information technology will take off is if people have confidence that their sensitive medical information will be protected. Without this assurance, we will never be able to realize the benefits that electronic systems offer. Democrats pushed for privacy protections during last year's debate, but our pleas fell on deaf ears. I hope that the GAO report and Mr. Feldman's resignation will finally be the wake-up call this administration needs to begin taking this issue seriously."
At the HIMSS conference on March 1, in an apparent effort to counter these developments, Dr. Kolodner announced that HHS plans to contract for a pilot "network of networks" that would allow healthcare consumers to control the flow of their own electronic health information. Dr. Kolodner explained that the government's requests for proposals on a trial implementation of the National Health Information Network (NHIN) will require bidders to include specific technical capabilities for enabling such consumer control.
Computerized health records fall into two basic categories, personal health records, or PHRs, and electronic health records, or EHRs. PHRs generally are created by health plans and insurers for their members based on benefit claims records while EHRs are created by healthcare providers for their patients based on the medical care provided. Efforts are under way to make PHRs and EHRs transportable and interoperable. HHS is working with others to develop the NHIN, which would serve as a nationwide patient registry for electronic health records maintained locally.
Provider medical records are subject to HIPAA privacy and security rules if the provider, also known as a HIPAA-covered entity, engages in electronic claim transactions. Because Medicare generally mandates the submission of electronic claims, except for small practices, most facilities and medical groups are HIPAA-covered entities. However, gaps in the HIPAA privacy and security rule coverage do exist among providers, and often the state privacy laws applicable to those non-covered entities are not as strict as the HIPAA rules. While the HIPAA law treats healthcare claim clearinghouses as covered entities, it did not contemplate the creation of healthcare record clearinghouses such as the regional health care organizations, or RHIOs, and the NHIN.
Health plan and insurer claim records that form the basis for PHRs are subject to the HIPAA privacy and security rules. Because the HIPAA law expressly was developed to encourage the use of electronic claim transactions, one might expect that there would be less controversy over PHR privacy protections, but that is not the case.
At its March 13, 2007 meeting, HHS's American Health Information Community approved, with some dissension, a consumer empowerment workgroup recommendation that product certification be made available for insurer record-based personal health records, according to Government HIT magazine and Healthcare IT News. The dissidents complained that certification is premature and could stifle innovation and that certification standards cannot assure privacy and security protections.
The tensions are evident as the nation's healthcare providers increasingly move toward paperless records. But with all the promises of built-in privacy protections, and the doubts of skeptical healthcare consumers, the outcome is not yet certain.
Congress is focusing attention on privacy and other data security issues with legislation, including the Personal Data Privacy and Security Act of 2007 (S. 495) and the Personalized Health Information Act of 2007 (H.R. 1368). The ongoing debate is worth your attention.
David Ermer is the Managing Partner of Gordon & Ermer, Washington, D.C. He is general counsel to a trade association of Federal Employees Health Benefits Plans. Read David Ermer's blog at www.gordon-ermer.com/FEHBlog.html, or reach him at +202.833.3400.