45 CFR § 171.303 - Licensing exception - When will an actor's practice to license interoperability elements in order for electronic health information to be accessed, exchanged, or used not be considered information blocking?
An actor's practice to license interoperability elements for electronic health information to be accessed, exchanged, or used will not be considered information blocking when the practice meets all of the following conditions.
(1) Begin license negotiations with the requestor within 10 business days from receipt of the request; and
(2) Negotiate a license with the requestor, subject to the licensing conditions in paragraph (b) of this section, within 30 business days from receipt of the request.
(1) Scope of rights. The license must provide all rights necessary to:
(2) Reasonable royalty. If the actor charges a royalty for the use of the interoperability elements described in paragraph (a) of this section, the royalty must be reasonable and comply with the following requirements:
(i) The royalty must be nondiscriminatory, consistent with paragraph (b)(3) of this section.
(ii) The royalty must be based solely on the independent value of the actor's technology to the licensee's products, not on any strategic value stemming from the actor's control over essential means of accessing, exchanging, or using electronic health information.
(iii) If the actor has licensed the interoperability element through a standards developing organization in accordance with such organization's policies regarding the licensing of standards-essential technologies on terms consistent with those in this exception, the actor may charge a royalty that is consistent with such policies.
(3) Non-discriminatory terms. The terms (including royalty terms) on which the actor licenses and otherwise provides the interoperability elements must be non-discriminatory and comply with the following requirements:
(i) The terms must be based on objective and verifiable criteria that are uniformly applied for all similarly situated classes of persons and requests.
(ii) The terms must not be based in any part on -
(A) Whether the requestor or other person is a competitor, potential competitor, or will be using electronic health information obtained via the interoperability elements in a way that facilitates competition with the actor; or
(4) Collateral terms. The actor must not require the licensee or its agents or contractors to do, or to agree to do, any of the following -
(i) Not compete with the actor in any product, service, or market.
(ii) Deal exclusively with the actor in any product, service, or market.
(iii) Obtain additional licenses, products, or services that are not related to or can be unbundled from the requested interoperability elements.
(iv) License, grant, assign, or transfer to the actor any intellectual property of the licensee.
(i) The agreement states with particularity all information the actor claims as trade secrets; and
(ii) Such information meets the definition of a trade secret under applicable law.
(2) Impeding the efficient development, distribution, deployment, or use of an interoperable product or service for which there is actual or potential demand.
(3) Degrading the performance or interoperability of the licensee's products or services, unless necessary to improve the actor's technology and after affording the licensee a reasonable opportunity to update its technology to maintain interoperability.