45 CFR § 171.302 - Fees exception - When will an actor's practice of charging fees for accessing, exchanging, or using electronic health information not be considered information blocking?

§ 171.302 Fees exception - When will an actor's practice of charging fees for accessing, exchanging, or using electronic health information not be considered information blocking?

An actor's practice of charging fees, including fees that result in a reasonable profit margin, for accessing, exchanging, or using electronic health information will not be considered information blocking when the practice meets the conditions in paragraph (a) of this section, does not include any of the excluded fees in paragraph (b) of this section, and, as applicable, meets the condition in paragraph (c) of this section.

(a) Basis for fees condition.

(1) The fees an actor charges must be -

(i) Based on objective and verifiable criteria that are uniformly applied for all similarly situated classes of persons or entities and requests;

(ii) Reasonably related to the actor's costs of providing the type of access, exchange, or use of electronic health information to, or at the request of, the person or entity to whom the fee is charged;

(iii) Reasonably allocated among all similarly situated persons or entities to whom the technology or service is supplied, or for whom the technology is supported; and

(iv) Based on costs not otherwise recovered for the same instance of service to a provider and third party.

(2) The fees an actor charges must not be based on -

(i) Whether the requestor or other person is a competitor, potential competitor, or will be using the electronic health information in a way that facilitates competition with the actor;

(ii) Sales, profit, revenue, or other value that the requestor or other persons derive or may derive from the access, exchange, or use of the electronic health information;

(iii) Costs the actor incurred due to the health IT being designed or implemented in a non-standard way, unless the requestor agreed to the fee associated with the non-standard design or implementation to access, exchange, or use the electronic health information;

(iv) Costs associated with intangible assets other than the actual development or acquisition costs of such assets;

(v) Opportunity costs unrelated to the access, exchange, or use of electronic health information; or

(vi) Any costs that led to the creation of intellectual property, if the actor charged a royalty for that intellectual property pursuant to § 171.303 and that royalty included the development costs for the creation of the intellectual property.

(b) Excluded fees condition. This exception does not apply to -

(1) A fee prohibited by 45 CFR 164.524(c)(4);

(2) A fee based in any part on the electronic access of an individual's EHI by the individual, their personal representative, or another person or entity designated by the individual;

(3) A fee to perform an export of electronic health information via the capability of health IT certified to § 170.315(b)(10) of this subchapter for the purposes of switching health IT or to provide patients their electronic health information; and

(4) A fee to export or convert data from an EHR technology that was not agreed to in writing at the time the technology was acquired.

(c) Compliance with the Conditions of Certification condition. Notwithstanding any other provision of this exception, if the actor is a health IT developer subject to the Conditions of Certification in § 170.402(a)(4), § 170.404, or both of this subchapter, the actor must comply with all requirements of such conditions for all practices and at all relevant times.

(d) Definition of Electronic access. The following definition applies to this section:

Electronic access means an internet-based method that makes electronic health information available at the time the electronic health information is requested and where no manual effort is required to fulfill the request.