45 CFR 164.306 - Security standards: General rules.
(a)General requirements. Covered entities and business associates must do the following:
(2) Protect against any reasonably anticipated threats or hazards to the security or integrity of such information.
(4) Ensure compliance with this subpart by its workforce.
(b)Flexibility of approach.
(1) Covered entities and business associates may use any security measures that allow the covered entity or business associate to reasonably and appropriately implement the standards and implementation specifications as specified in this subpart.
(iii) The costs of security measures.
(iv) The probability and criticality of potential risks to electronic protected health information.
(c)Standards. A covered entity or business associate must comply with the applicable standards as provided in this section and in §§ 164.308, 164.310, 164.312, 164.314 and 164.316 with respect to all electronic protected health information.
(d)Implementation specifications. In this subpart:
(1) Implementation specifications are required or addressable. If an implementation specification is required, the word “Required” appears in parentheses after the title of the implementation specification. If an implementation specification is addressable, the word “Addressable” appears in parentheses after the title of the implementation specification.
(2) When a standard adopted in § 164.308, § 164.310, § 164.312, § 164.314, or § 164.316 includes required implementation specifications, a covered entity or business associate must implement the implementation specifications.
(i) Assess whether each implementation specification is a reasonable and appropriate safeguard in its environment, when analyzed with reference to the likely contribution to protecting electronic protected health information; and
(A) Implement the implementation specification if reasonable and appropriate; or
(B) If implementing the implementation specification is not reasonable and appropriate -
$(1) Document why it would not be reasonable and appropriate to implement the implementation specification; and
$(2) Implement an equivalent alternative measure if reasonable and appropriate.
(e)Maintenance. A covered entity or business associate must review and modify the security measures implemented under this subpart as needed to continue provision of reasonable and appropriate protection of electronic protected health information, and update documentation of such security measures in accordance with § 164.316(b)(2)(iii).