HHS' Office of the National Coordinator for Health Information Technology has released for public comment a 42-page draft document intended to ultimately guide and perhaps even control healthcare organizations in how patients' can express their “preferences” on the use of their medical records and healthcare data.
The so-called
Consumer Preferences Draft Requirements Document is equivalent to what was called a “use case” during the Bush administration. Use cases were chosen by the then-guiding health IT advisory body, the American Health Information Community, and then handed over to the Health Information Technology Standards Panel, or HITSP, for identification and harmonization of needed standards to carry out the tasks outlined in the use case.
As in the Bush administration, patients are called “consumers” throughout the latest ONC document under the leadership of David Blumenthal, President Barack Obama's choice as national coordinator. Then as now, selection of the specific standards to implement the patient choices in the draft document was left in the draft document for others to make. The level of control patients will have over the use of their medical information also was left open in the draft document, but its authors at least contemplate applying whatever constraints are chosen to the concept of “meaningful use.” Only providers that use electronic health record systems in a “meaningful" manner may qualify for the estimated $34 billion in federal subsidies to purchase and operate EHRs under the American Recovery and Reinvestment Act of 2009, or stimulus law. Fleshing out what constitutes "meaningful use" remains a work in progress at HHS and the CMS, the latter of which will be responsible for administering the bulk of the EHR subsidy program and will set the final meaningful use standards.
The preferences document reflects that the rulemaking on the appropriate role of patient control and consent remains in flux. For example, the draft says: “It is important to note that consumers, at the highest level, require the capability to opt in or opt out of the exchange of their health information. Consumers may also request that only certain classes of information be shared. These classes of information and preferences could be classified at varying levels of granularity. Defining the needed levels of granularity is not the focus of this Consumer Preferences Requirements Document.”
Granularity refers to how finely tuned patient control might be, e.g., whether a patient might exclude access to his or her entire medical record, in effect, lock it down completely; or in contrast, allow access to only specified providers for specific data elements in their records, such as granting only their primary-care physician access to their diagnosis of depression and any prescriptions related to that diagnosis. The privacy provisions of the stimulus law, for example, requires providers to honor a patient's request to withhold that patient's records for a specific treatment from their insurance companies if the patient pays for a treatment out of pocket.
The draft contains what it calls a comprehensive, but not exhaustive, list of classes of such information that might be subject to patient preferences, and is “only intended to be a guide for development of standards” but does not preclude the use of any existing standards, including those already approved by the HITSP.
The list includes specific clinical information, such as diagnoses, test results and treatments, as well as role-based constraints that would allow access only to certain providers, or time-based access, patient permissions to access the records that would expire after a certain period of time.
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