[Code of Federal Regulations]
[Title 45, Volume 1]
[Revised as of October 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 45CFR164.306]

[Page 736-737]
 
                        TITLE 45--PUBLIC WELFARE
 
                           AND HUMAN SERVICES
 
PART 164_SECURITY AND PRIVACY--Table of Contents
 
Subpart C_Security Standards for the Protection of Electronic Protected 
                           Health Information
 
Sec. 164.306  Security standards: General rules.

    (a) General requirements. Covered entities must do the following:
    (1) Ensure the confidentiality, integrity, and availability of all 
electronic protected health information the covered entity creates, 
receives, maintains, or transmits.
    (2) Protect against any reasonably anticipated threats or hazards to 
the security or integrity of such information.
    (3) Protect against any reasonably anticipated uses or disclosures 
of such information that are not permitted or required under subpart E 
of this part.
    (4) Ensure compliance with this subpart by its workforce.
    (b) Flexibility of approach. (1) Covered entities may use any 
security measures that allow the covered entity to reasonably and 
appropriately implement the standards and implementation specifications 
as specified in this subpart.
    (2) In deciding which security measures to use, a covered entity 
must take into account the following factors:
    (i) The size, complexity, and capabilities of the covered entity.
    (ii) The covered entity's technical infrastructure, hardware, and 
software security capabilities.
    (iii) The costs of security measures.
    (iv) The probability and criticality of potential risks to 
electronic protected health information.
    (c) Standards. A covered entity must comply with the standards as 
provided in this section and in Sec. 164.308, Sec. 164.310, Sec. 
164.312, Sec. 164.314, and Sec. 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 Sec. 164.308, Sec. 164.310, Sec. 
164.312, Sec. 164.314, or Sec. 164.316 includes required 
implementation specifications, a covered entity must implement the 
implementation specifications.
    (3) When a standard adopted in Sec. 164.308, Sec. 164.310, Sec. 
164.312, Sec. 164.314, or Sec. 164.316 includes addressable 
implementation specifications, a covered entity must--
    (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

[[Page 737]]

the entity's electronic protected health information; and
    (ii) As applicable to the entity--
    (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. Security measures implemented to comply with 
standards and implementation specifications adopted under Sec. 164.105 
and this subpart must be reviewed and modified as needed to continue 
provision of reasonable and appropriate protection of electronic 
protected health information as described at Sec. 164.316.

[68 FR 8376, Feb. 20, 2003; 68 FR 17153, Apr. 8, 2003]