In § 164.506(e), we are proposing that covered plans and providers include specific terms in their contract with each business partner. One of the required terms would be that the business partner must provide for inspection and copying of protected health information as provided in this section. Because our authority is limited by HIPAA to the covered entities, we must rely upon covered plans and providers to ensure that all of the necessary protected health information provided by the individual to the plan or provider is available for inspection and copying. We would require covered plans and providers to provide access to information held in the custody of a business partner when it is different from information maintained by the covered plan or provider. We identified two instances where this seemed appropriate: when the protected health information is only in the custody of a business partner and not in the custody of the covered plan or provider; and when protected health information has been materially altered by a business partner. We are soliciting comment on whether there are other instances where access should be provided to protected health information in the custody of a business partner.
Other than in their capacity as business partners, we are not proposing to require clearinghouses to provide access for inspection and copying. As explained above in section II.C.5, clearinghouses would usually be business partners under this proposed rule and therefore they would be bound by the contract with the covered plan or provider. See proposed §164.506(e). We carefully considered whether to require clearinghouses to provide access for inspection and copying above and beyond their obligations as a business partner, but determined that the typical clearinghouse activities of translating record formats and batching transmissions do not involve setting up designated record sets on individuals. Although the data maintained by the clearinghouse is protected health information, it is normally not accessed by individual identifier and an individual’s records could not be found except at great expense. In addition, although clearinghouses process protected health information and discover errors, they do not create the data and make no changes in the original data. They, instead, refer the errors back to the source for correction. Thus, individual access to clearinghouse records provides no new information to the individual but could impose a significant burden on the industry.
As technology improves it is likely that clearinghouses will find ways to take advantage of databases of protected health information that aggregate records on the basis of the individual subject of the information. This technology would allow more cost- effective access to clearinghouse records on individuals and therefore access for inspection and copying could be appropriate and reasonable.