National Committee on Vital and Health Statistics
National Health Information Network
January 23, 2007
First, a disclaimer; as Chairman and CEO of Home Access Health Corporation (HAHC), I am capable of describing our company’s business, it’s current approaches to protection of Privacy and Confidentiality, and, general views with respect to Nationwide Health Information Network (NHIN)…however, I have minimal depth of knowledge with respect to information systems, regulatory, compliance, quality control, legal or other important bodies of knowledge that are most important to this Committee for purposes of developing positions and policies for NHIN.
With that said, I hope my remarks provide some value to the Committee; and, on behalf of HAHC, I am honored that you requested our testimony.
When HHS requested our presence, I was told that it came to the Committee’s attention that our company was recognized as “doing things right” with respect to Privacy, Confidentiality, etc. despite that we are not covered by the HIPAA Privacy Rule. [Labs are considered health care providers under the HIPAA Rule, but they are only covered if they are doing insurance transactions.]
While I would like to take credit for being good, voluntary “corporate citizens”, I have to admit that our company believed it had an imperative, legally and otherwise, to adhere to HIPAA despite the fact that we were not conducting insurance transactions.
In order to give the Committee an understanding why HAHC focuses much attention on Privacy, Confidentiality, and Medical Reporting, allow me to provide an overview of HAHC’s background and business.
HAHC was founded in 1993 as a Personal Convenience Diagnostics company; our initial focus was to develop a methodology that would allow individuals at-risk for HIV an opportunity to get tested for this infectious and deadly disease with full confidence that they could do so with absolute privacy protection of their testing and results. (Of note, many individuals at-risk for HIV simply will not test using traditional testing methods because they fear stigma and/or discrimination.)
“Anonymous” At-Home HIV Testing System
FDA approved the Home Access HIV-1 Test System in 1996; this “system” includes an at-home collection kit (lancet, band-aid, directional insert, postage paid return mailer, etc.) with its primary component being a blood collection card and associated Home Access Code Number (HACN). Individuals provide anonymous informed consent for testing by writing their 11 digit HACN on the blood collection card and dating it. (The HACN is created by an algorithm-based system that includes check digits to assure numbers are authentic and are never replicated.)
Individuals are instructed to activate their test process by calling a toll free number and entering their HACN; they are then asked to “Opt-In” demographic and risk data. They are then instructed to provide a fingerstick sample and to tear off a wallet sized Home Access Code Number result-claim card and send the blood sample via pre-paid postage to HAHC’s laboratory.
Once at HAHC, the blood collection card is accessioned and scanned. The sample is then processed using an algorithm that calls for ELISA screening; repeat ELISA screening if the first test is reactive; and, if a repeat ELISA is reactive, an IFA confirmation test is run. (Of note, this testing method was clinically demonstrated to achieve “accuracy greater than 99.9%”.) Laboratory result information from the testing process is then loaded into the anonymous medical record file, launched via the Home Access Code Number, awaiting the person being tested to “call in for results”.
Individuals tested call a toll free telephone number and input their Home Access Code Number to receive results. Results are provided on an automated basis if negative; or, if positive – results, counseling and referrals are provided by a professional counselor that is under the direction of HAHC’s Medical Director and trained in CDC (Center for Disease Control) Client Centered Counseling methods.
This process absolutely guarantees that the individual is tested anonymously, resulted anonymously, and tracked anonymously. It is important to point out that there is no correlation and/or tracking of kits to units sold e.g. someone might buy a kit using their credit card but kits are prepackaged with Home Access Code Numbers inside the box with no external linkage to purchased kit data, purposely to avoid the possibility of correlating results…making results completely anonymous, totally private and confidential.
HIV testing, result delivery, and data tracking obviously required(s) extreme protection of individual’s privacy and confidentiality; HAHC answered these needs by developing a code numbered, anonymous testing system described above. Because our Corporate Philosophy was built on the imperative for Privacy and Confidentiality…HAHC continues take extra care to insure individuals testing with HAHC are afforded similar protections even if testing, results and tracking are not anonymous.
HAHC began developing infrastructure and controls for “confidential” testing and reporting as we developed a system for Hepatitis C (HCV) at-home testing. This “next generation – closed loop system” allowed for either anonymous or confidential testing, FDA approved it in 1999. HAHC primarily added confidential testing as an alternative to anonymous testing in order to satisfy demands of Public Health Departments and others to provide testing of individuals that “Opt-In” and consent to their “identification” allowing an opportunity to “close the loop” with individuals found infected but who had not accessed their test results.
In addition to supporting the Company’s FDA approved Hepatitis C testing services, this confidential testing and reporting system has been employed for various “Lookback” initiatives to assist hospitals and diagnostic laboratories to notify patients that prior diagnostic practices e.g. transfusions before 1992 may have exposed patients to certain diseases and to provide them confidential counseling and testing opportunities according to Federal guidance or other.
Home Access HIV Test System and Home Access Hepatitis Check were developed before HIPAA came into effect; however, FDA Quality System Regulations, Good Manufacturing Practices and Good Clinical Practices have governed the company’s laboratory and result delivery infrastructure. As part of these practices, the Company incorporated privacy and confidentiality into its quality control systems from day one.
In 2003, HAHC implemented its HIPAA policy as a component of our Good Manufacturing Practices process.
Most recently, HAHC has developed a new testing platform whereby a proprietary collection device is used to separate self-collected (fingerstick) red blood cells from serum in order to provide access to quantitative laboratory testing e.g. Fasting Plasma Glucose, Liver Enzymes, Lipids, etc. to help individuals avoid chronic diseases and/or to assist them and their doctors in keeping their disease(s) under control.
This new platform (branded: Accessa), will offer individuals/patients the same opportunity as the Hepatitis C system described above, to conduct anonymous or confidential testing and result delivery.
National Health Information Network
For some US citizens, particularly those that espouse Consumer Driven Healthcare, anonymous testing may be the only way that they will “Opt-In” for testing (HIV or other). For this reason and for freedom of choice, anonymous testing should always be available as an option to Americans. This raises the question: “should anonymous medical information connect with NHIN and if so, how”?
Similar to its position with HIPAA, HAHC will comply with NHIN guidance with respect to confidential, Opt-In testing if and when law is effected. From a small business perspective, my recommendation would be to develop the interface, certification & compliance process, etc. in the most simple and least-onerous way possible.
My personal view is that NHIN is a monumental task and challenge; on behalf of HAHC, I wish you good luck.
Tracey T. Powell