Standards for Privacy of Individually Identifiable Health Information. Final Privacy Rule Preamble.. Scalability


Wherever possible, the final rule provides a covered entity with flexibility to create policies and procedures that are best suited to the entity's current practices in order to comply with the standards, implementation specifications, and requirements of the rule. This allows the covered entity to assess its own needs in devising, implementing, and maintaining appropriate privacy policies, procedures, and documentation to address these regulatory requirements. It also will allow a covered entity to take advantage of developments and methods for protecting privacy that will evolve over time in a manner that is best suited to that institution. This approach allows covered entities to strike a balance between protecting privacy of individually identifiable health information and the economic cost of doing so within prescribed boundaries set forth in the rule. Health care entities must consider both factors when devising their privacy solutions. The Department assumes that professional and trade associations will provide guidance to their members in understanding the rule and providing guidance on how they can best achieve compliance. This philosophy is similar to the approach in the Transactions Rule.

The privacy standard must be implemented by all covered entities, regardless of size. However, we believe that the flexible approach under this rule is more efficient and appropriate then a single approach to safeguarding health information privacy. For example, in a small physician practice, the office manager might be designated to serve as the privacy official as one of many of her duties. In a large health plan, the privacy official position may require more time and greater privacy experience, or the privacy official may have the regular support and advice of a privacy staff or board. The entity can decide how to implement this privacy official requirement based on the entity's structure and needs.

The Department decided to use this scaled approach to minimize the burden on all entities, with an emphasis on small entities. The varying needs and capacities of entities should be reflected in the policies and procedures adopted by the organization and the overall approach it takes to achieve compliance.