NRPM: Standards for Privacy of Individually Identifiable Health Information. e. Plain language requirement.


We are proposing to apply a plain language requirement to notices developed by covered plans or providers under these proposed rules. A covered plan or provider could satisfy the plain language requirement if it made a reasonable effort to: organize material to serve the needs of the reader; write sentences in the active voice, use “you” and other pronouns; use common, everyday words in sentences; write in short sentences; and divide material into short sections.

We also considered proposing formatting specifications such as requiring the covered plan or provider to use easy-to-read design features (e.g., lists, tables, graphics, contrasting colors, and white space), type face, and font size in the notice. We are soliciting comment on whether these additional format specifications should be required.

The purpose of the notice proposed in the rules below is to tell the recipient how protected health information collected about them will be used. Recipients who cannot understand the entity’s notice would miss important information about their privacy rights and how the entity is protecting health information about them. One of the goals of this proposed rule is to create an environment of open communication and transparency with respect to the use and disclosure of protected health information. A lack of clarity in the notice could undermine this goal and create misunderstandings. Covered plans or providers have an incentive to make their notice statements clear and concise. We believe that the more understandable notices are, the more confidence the public will have in the entity’s commitment to protecting the privacy of health information.

It is important that the content of the notice be communicated to all recipients and therefore we would encourage the covered plan or provider to consider alternative means of communicating with certain populations. We note that any covered entity that is a recipient of federal financial assistance is generally obligated under title VI of the Civil Rights Act of 1964 to provide material ordinarily distributed to the public in the primary languages of persons with limited English proficiency in the recipients’ service areas. Specifically, this title VI obligation provides that, where a significant number or proportion of the population eligible to be served or likely to be directly affected by a federally assisted program need service or information in a language other than English in order to be effectively informed of or participate in the program, the recipient shall take reasonable steps, considering the scope of the program and the size and concentration of such population, to provide information in language appropriate to such persons. For entities not subject to title VI, the title VI standards provide helpful guidance for effectively communicating the content of their notices to non-English speaking populations.

We also would also encourage covered plans or providers to be attentive to the needs of individuals who cannot read. For example, an employee of the entity could read the notice to individuals upon request or the notice could be incorporated into a video presentation that is played in the waiting area.

The requirement of a printed notice should not be interpreted as a limitation. For example, if an individual who is requesting a notice from a covered plans or providers were to ask to receive the notice via e-mail, the requirements of this proposed rule could be met by providing the notice via e-mail. The proposed rule would not preclude the use of alternative forms of providing the notice and we would encourage covered plans or providers to use other forms of distribution, such as posting their privacy notices on their web sites. While this will not substitute for paper distribution when that is requested by an individual, it may reduce the number of requests for paper copies.