Would the Preventing Harm Exception cover a “blanket” several day delay on the release of laboratory or other test results to patients so an ordering clinician can evaluate each result for potential risk of harm associated with the release?

No. Blanket delays that affect a broad array of routine results do not qualify for the Preventing Harm Exception. The Preventing Harm Exception is designed to cover only those practices that are no broader than necessary to reduce a risk of harm to the patient or another person.

As we discussed in the Cures Act Final Rule, a clinician generally orders tests in the context of a clinician-patient relationship. In the context of that relationship, the clinician ordering a particular test would know the range of results that could be returned and could prospectively formulate, in the exercise of their professional judgment, an individualized determination for the specific patient that:

• withholding the results of the particular test(s) from the patient would substantially reduce a risk to the patient’s or another person’s life or physical safety
  - or -
• that withholding the results of the particular test(s) from a representative of the patient would substantially reduce a risk of substantial harm to the patient or another person.

Such individualized determinations made in good faith by an ordering clinician, in the exercise of their professional judgment and in the context of the treatment relationship within which they order the test, would satisfy the type of risk and type of harm conditions of the Preventing Harm Exception. Actors, including but not limited to the ordering clinician, could implement practices in reliance on such determinations and the Preventing Harm Exception would cover such practices so long as the practices also satisfy the other four conditions of the exception.