Explosive growth in digital health over the last few years means there are many developers and managers who haven’t worked under HIPAA before. This guide is written for startups (and small businesses operating online) who could use some help with the basics of HIPAA compliance.
(a) General requirements. Covered entities and business associates must do the following:
(1) Ensure the confidentiality, integrity, and availability of all electronic protected health information the covered entity or business associate 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 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.
(2) In deciding which security measures to use, a covered entity or business associate must take into account the following factors:
(i) The size, complexity, and capabilities of the covered entity or business associate.
(ii) The covered entity's or the business associate'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 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
(ii) As applicable to the covered entity or business associate--
(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).
[68 FR 8376, Feb. 20, 2003; 68 FR 17153, Apr. 8, 2003; 78 FR 5693, Jan. 25, 2013]