SELECT QUOTES: Judge Allan Klein's Ruling on State Plan to Collect Patient Data Without Patient Consent

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Addressing Public Opposition to the Rule

Striking an appropriate balance between personal privacy and healthcare research is ultimately the task of the legislature. To date, the legislature has chosen to allow the collection and use of data for research purposes, but only if the Department takes steps to protect individual privacy. The Administrative Law Judge has taken a "hard look" at the privacy protections in these proposed rules. He believes that the Department's proposals do meet the standard set by the legislature; in fact, they go well beyond the minimal efforts required to comply with the statutes.

Most of the public commentators, however, disagree with the legislature's balancing of privacy concerns and research needs. As many of them look at the pros and cons of the Department's proposals, they strike a different balance. Many of them end up concluding that the harm that would flow from release of private information is so severe that it overwhelms whatever benefits would accrue from the database, even if the risk of release is low. They do not want their data to leave the doctor's office without their consent under any conditions.

It is not possible to resolve all the points of view expressed in this record. There is no system of reasonable safeguards that will satisfy both the needs of the researchers and the concerns of all of the public. The legislature has struck it's [sic] balance, and the Department has designed a system that is consistent with the legislative balance. Those people who just fundamentally disagree with the legislature's choice must address their arguments to the legislature.

(Judge Allan W. Klein, MEMORANDUM, Report of the Administrative Law Judge, pp. 37-38)

Addressing Privacy and Research

"The Department has shown that there are significant benefits in reducing costs to the public, improving treatment for patients, informing consumer choice in medical care, and preventing inadvertent harm when receiving medical care. Each of these reasons is a sufficient justification for establishing a database populated with billing data created for payment of medical services, so long as patient privacy can be protected." (p 7, no. 14)

"[T]he Department submitted a published study from the Mayo Clinic on the potential for bias in medical research based on issues arising from obtaining consent. That study concluded that requiring consent before including data caused the database to be nonrepresentative of the general population. The Department has shown the need to obtain encounter data without obtaining the consent of the individual patient."(pp 7-8, no. 15)

"No court has determined such data collection to be constitutionally prohibited." (p. 9, no. 20)

"[T]here has been no showing that the proposed rule infringes on a protected privacy right." (p. 11, no. 25)

"[T]he area of individual ethnicity and race relies on self-definition and lacks objective standards. But these concerns do not obliterate the continued usefulness of these data elements for researchers....The prevalence of such research demonstrates that collecting data elements on race and ethnicity are needed and reasonable." (p. 14, no. 35)

"The standards established in these rules are sufficient to protect the privacy interests of those individuals whose data is included in the database." (p. 20, no. 50)

"When data is being published there is a requirement that the identity of any individual not be disclosed. There is no such protection for providers or group purchasers. Indeed, identifying aggregate health care outcomes by provider is a recognized means of promoting informed patient choice." (p. 21, no. 56)

"[S]ubpart 4 assures that the use and oversight of the database will [be] conducted in full public view. This degree of oversight directly addresses concerns that the database could be used to improperly invade the privacy of individuals." p. 22, no. 59)

"[P]rivacy interests are protected by the removal of any information that could lead to the re-identification of the individual within the summary data."

"Subpart 2, with the modifications proposed by the Department, is needed and reasonable to ensure that the fundamental right of individuals to privacy is protected." (p. 28, no. 75)

"The dollar-amount of benefits derived from the research applications of the database is likely to far exceed the cost of establishing and maintaining that database." (p. 35, no. 101)