We propose that covered entities be prohibited, except in the case of clinical trial as described below, from conditioning treatment or payment for health care on obtaining an authorization for purposes other than treatment, payment or health care operations. This is intended to prevent covered plans and providers from coercing individuals into signing an authorization for a disclosure that is not necessary for treatment, payment or health care operations. For example, a provider could not refuse to treat an individual because the individual refused to authorize a disclosure to a pharmaceutical manufacturer for the purpose of marketing a new product.
We propose one exception to this provision: health care providers would be permitted to condition treatment provided as part of a clinical trial on obtaining an authorization from the individual that his or her protected health information could be used or disclosed for research associated with such clinical trial. Permitting use of protected health information is part of the decision to receive care through a clinical trial, and health care providers conducting such trials should be able to condition participation in the trial on the individual’s willingness to authorize that his or her protected health information be used or disclosed for research associated with the trial. We note that the uses and disclosures would be subject to the requirements of § 164.510(j) below.
Under the proposal, a covered entity would not be permitted to obtain an authorization for use or disclosure of information for treatment, payment or health care operations unless required by applicable law. Where such an authorization is required by law, however, it could not be combined in the same document with an individual authorization to use or disclosure of protected health information for any purpose other than treatment, payment or health care operations (e.g., research). We would require that a separate document be used to obtain any other individual authorizations to make it clear to the individual that providing an authorization for such other purpose is not a condition of receiving treatment or payment.