Governance & Risk Management , HIPAA/HITECH , Privacy
Health Research Bill Would Alter HIPAADraft Measure Calls for Big Privacy Changes
Some privacy experts are concerned that a bipartisan 21st Century Cures bill, as drafted, would weaken HIPAA privacy protections for patient information. The measure, among other things, is designed to help the medical community speed up the development of new drugs and treatments.
A discussion draft unveiled on April 29 proposes that the Secretary of the Department of Health and Human Services would "revise or clarify" the HIPAA Privacy Rule's provisions on the use and disclosure of protected health information for research purposes.
Under the current HIPAA Privacy Rule, PHI is allowed be used or disclosed by a covered entity for healthcare treatment, payment and operations without authorization by the patient. If a proposed provision in the draft legislation is signed into law, patient authorization would not be required for PHI use or disclosure for research purposes if covered entities or business associates, as defined under HIPAA, are involved.
The draft was jointly issued by Fred Upton, R-Mich., chairman of the House Energy and Commerce Committee, Rep. Diana DeGette, D-Col., ranking member of the Oversight and Investigations Subcommittee, and several other Republican and Democratic House members. Work on the legislation began a year ago, and a markup version of the bill, which covers a broad range of topics, is expected this week.
"Most significantly, the bill would require HHS to revise the HIPAA regulations so that uses and disclosures for research are treated the same as uses and disclosures for a covered entity's own healthcare operations, as long as any disclosures go to a HIPAA covered entity or business associate," says privacy attorney Adam Greene of the law firm Davis Wright Tremaine.
"This seems to mean that such research uses and disclosures could occur without an individual's authorization or an Institutional Review Board's or Privacy Board's waiver of authorization," he says. Essentially, research uses and disclosures would only be restricted by the 'minimum necessary' standard, he says. The HIPAA Privacy Rule generally requires covered entities to take reasonable steps to limit the use or disclosure of, and requests for, PHI to the "minimum necessary" to accomplish the intended purpose.
Backers of the bill say it's needed because it has the potential of helping to knock down barriers to advancing medical innovation and treatment, including tapping breakthroughs in molecular medicine, genomics and related health technologies.
"For the first time ever, we in Congress are going to take a comprehensive look at what steps we can take to accelerate the pace of cures in America," DeGette says in a statement. We are looking at the full arc of this process - from the discovery of clues in basic science, to streamlining the drug and device development process, to unleashing the power of digital medicine and social media at the treatment delivery phase."
A source at the Energy and Commerce Committee say the markup of the bill is expected on May 14. "We are very careful to limit the potential to use PHI for research purposes only to covered entities and business associates working for covered entities - trusted organizations that have a relationship with the individual and that are already allowed to use PHI to improve care," the source says. "The committee wants those covered entities to not only improve care in their own institution, but be able to publish the findings of their research - without disclosing any identifiable PHI, of course. The bill ensures that PHI used for research is fully covered by the protections of the HIPAA privacy, security and breach reporting rules."
But some privacy experts say the bill goes too far in potentially removing patient privacy protections when it comes to the use of PHI for research.
The privacy provisions, as they appear in the draft bill, "roll back essential protections of the control that patients have over how their information is used and disclosed," says privacy attorney David Holtzman, vice president of compliance at security consulting firm CynergisTek. "Because PHI used for research could involve genetic information, the [research exemption] could potentially provide [use and disclosure] of information on the genetic traits of family members. Once that data is out, you can't get it back."
Other Privacy Provisions
The bill also proposes providing individuals with one-time authorization that would allow the use and disclosure of their PHI for future research purposes.
"In cases where the covered entity or business associate needs an authorization, it would require HHS to put its interpretation into regulation that an authorization can encompass future research studies," Greene says. The bill's proposals appear to further expand the authority to use and disclose protected health information for research and codify in regulation a recent HHS interpretation allowing an advanced authorization for future research."
While HHS indicated in the HIPAA Omnibus Rule commentary that an authorization may authorize uses and disclosures of protected health information for future research studies, Greene says, "this bill would require HHS to put this into the HIPAA regulations themselves."
Deborah C. Peel, M.D., founder of Patient Privacy Rights, an advocacy group, tells Information Security Media Group the future-research proposal is "a very bad idea," adding "no data should ever be used except for a single purpose. It's especially bad because today we have no 'chain of custody' for our health data. It's impossible to know where in the world it is or how it's being used. The risks of today's ubiquitous data surveillance and collection systems are unknown. When has it ever been smart to agree to something you have no understanding of?"
Another provision in the draft bill would give researchers remote access to PHI maintained by a covered entity if ''appropriate security and privacy safeguards are maintained by the covered entity and the researcher, and the protected health information is not copied or otherwise retained by the researcher."
Greene says that in cases where the disclosure of PHI is to a researcher that is not a covered entity or business associate, "the statute would broaden the permission for disclosing protected health information preparatory to research, allowing a covered entity to grant remote access to the researcher, rather than requiring that the review occurs at the facility."
Additionally the bill would make changes regarding PHI used in paid research. "The proposed bill appears to also allow covered entities and business associates to receive remuneration, such as payments, in exchange for disclosing protected health information for research," Greene notes. "Currently, such payment would be limited to the reasonable cost for preparation and transmittal of the protected health information."
The remuneration proposal also diminishes patients' control over how their PHI is used for paid research, Holtzman says. "The proposals remove key reforms in the HITECH Act [HIPAA Omnibus final rule] that require specific [patient] authorization for disclosures of information when money is changing hands," Holtzman says. "That [HITECH provision] is to give an individual a choice when there is remuneration involved. The proposal would roll back important rights requiring patient permission when their health information is disclosed in exchange for payment."
More Scrutiny Needed
Holtzman says he hopes the provisions in the draft bill are thoroughly vetted before the legislation progresses further. "This document appears to be in the early stages. I trust that the privacy community would undergo exhaustive debate and review of this document at it develops."
Greene predicts that the proposal "may garner strong views from both the research community and privacy advocates, with researchers perhaps indicating that HIPAA is standing in the way of good research and that these changes are necessary, while some privacy advocates may claim that these changes go too far in allowing uses and disclosures without an individual's consent or authorization.
Peel, the consumer advocate, contends: "These new provisions are really out-of-date and clearly designed for paper consents - a total nightmare."
Under the current language in the bill, HHS would be required to make the changes to HIPAA "not later than 12 months after the date of the enactment of the Act."