The Stark and anti-kickback waivers were spelled out in a pair of documents released Aug. 8, 2006, by the CMS and the HHS inspector generals office. According to these rules, there are two routes to interoperability through which a hospital-subsidized electronic health-record system qualifies for a waiver. One is that the system be tested and certified by an organization given deeming authority by HHS. HHS Secretary Mike Leavitt granted such authority to the Certification Commission for Healthcare Information Technology in October 2006. The other way is for a hospital to attest that the EHR it is offering physicians is interoperable using a much higher standard than CCHIT is currently using. The rule states: We are defining interoperable to mean that, at the time of the donation, the software is able to (1) communicate and exchange data accurately, effectively, securely and consistently with different information technology systems, software applications and networks, in various settings, and (2) exchange data such that the clinical or operational purpose and meaning of the data are preserved and unaltered.
The rule further states: Interoperability must apply in various settings, meaning that the software must be interoperable with respect to systems, applications and networks that are both internal and external to the donors or physician recipients systems, applications and networks. In other words, software will not be considered interoperable if it is capable of communicating or exchanging data only within a limited healthcare system or community.