| 1 | 
			General HIPAA 
			Compliance Policy | 
			164.104 
			164.306 
			HITECH 13401 | 
			Covered Entities and Business Associates, as defined in HIPAA and HITECH, must comply with all required parts and subparts of the regulations that apply to each type of Entity. | 
		
		
			| 2 | 
			Policies & Procedures 
			General Requirement | 
			164.306; 164.316 
			164.312(b)(1) 
			164.530(i) | 
			Implement reasonable and appropriate P&Ps to comply with all standards, implementation specifications, or other requirements. P&P changes must be appropriately documented. | 
		
		
			| 3 | 
			Documentation Policy  
			Requirement | 
			
			 164.530(j)(1)(ii) 
			164.530(j)(1)(iii) 
			164.312(b)(2)(i) 
			164.316 
			 | 
			Maintain all P&Ps in written (may be electronic) form. If an action, activity or assessment must be documented, maintain written (may be electronic) records of all. | 
		
		
			| 4 | 
			Documentation 
			Retention Policy 
			Requirement | 
			164.316 
			164.530(j) | 
			Retain all required documentation for 6 years from the date of its creation or the date when it last was in effect, whichever is later. | 
		
		
			| 5 | 
			Documentation Availability Policy 
			Requirement | 
			164.310 
			164.316 
			164.530(j) | 
			Make documentation available to those persons responsible for implementing the Policies and/or Procedures to which the documentation pertains. | 
		
		
			| 6 | 
			Documentation Updates Policy 
			Requirement | 
			164.310 
			164.316 
			164.530(j) | 
			Review documentation periodically and update as needed, in response to environmental or operational changes affecting the security of PHI. | 
		
		
			| 7 | 
			HHS Investigations Policy | 
			160.308 
			164.310 
			164.312 | 
			CEs and BAs must implement policies & procedures to assure compliance with HHS investigation & recordkeeping requirements. | 
		
		
			| 8 | 
			Breach Notification Policy | 
			164.400 to 
			164.414 | 
			Requires CEs and BAs to comply with all Breach Notification requirements: risk analysis; determination of potential harm; notifications. | 
		
		
			| 9 | 
			Assign Privacy Official Policy | 
			164.530(a) | 
			CEs and BA must assign an individual for all Privacy-related activities and compliance efforts; and to accept and process complaints. | 
		
		
			| 10 | 
			State Law Preemption Policy | 
			160.201 to 
			160.205 | 
			CEs and BAs must analyze and assess state law requirements related to data privacy & security; and HIPAA preemption impacts of state laws. | 
		
		
			| 11 | 
			HIPAA Training Policy | 
			164.530(b) | 
			CEs and BAs must train all affected workforce members on their Policies & Procedures, as well as the basics of HIPAA, as needed. | 
		
		
			| 12 | 
			PHI Uses & Disclosures Policy  | 
			164.502 to 
			164.514 | 
			CEs and BAs must establish methods and procedures to assure that all PHI uses & disclosures are in accord with HIPAA regs. | 
		
		
			| 13 | 
			Patient Rights Policy | 
			164.520 to 
			164.528 | 
			CEs (and BAs optionally) must implement policies & procedures to assure the lawful provision of Patient Rights as called for in HIPAA regs. | 
		
		
			| 14 | 
			Complaints Policy | 
			164.530(d) 
			164.530(a) | 
			CEs and BAs must establish methods and procedures to assure the proper handling of, and response to, all complaints received. | 
		
		
			| 15 | 
			Risk Management 
			Process Policy 
			Required | 
			164.302 to 
			164.318 | 
			Establishes the overall Risk Management process that CEs and BAs must implement to meet Privacy & Security Rule compliance requirements. | 
		
		
			| 16 | 
			Risk Analysis 
			Required Standard | 
			164.308(a)(1) | 
			Conduct assessment of potential risks and vulnerabilities to the confidentiality, integrity, and availability of ePHI held by the entity. | 
		
		
			| 17 | 
			Risk Management 
			Required Standard | 
			164.308(a)(1) | 
			Implement security measures sufficient to reduce risks and vulnerabilities to a reasonable and appropriate level to comply with Sec. 164.306(a). | 
		
		
			| 18 | 
			Sanction Policy 
			Required Standard | 
			164.308(a)(1) | 
			Apply appropriate sanctions against workforce members who fail to comply with the security policies and procedures of the covered entity. | 
		
		
			| 19 | 
			Information System 
			Activity Review 
			Required Standard | 
			164.308(a)(1) | 
			Implement procedures to regularly review information system activity: audit logs; access reports; and security incident reports; etc. | 
		
		
			| 20 | 
			Assigned Security 
			Responsibility 
			Required Standard | 
			164.308(a)(2) | 
			Assign security responsibility. Identify Security Official responsible for development and implementation of required P&Ps. | 
		
		
			| 21 | 
			Authorization & Supervision Policy 
			Addressable Standard | 
			164.308(a)(3) | 
			Implement procedures for authorization and/or supervision of workers who work with ePHI or in locations where it might be accessed. | 
		
		
			| 22 | 
			Workforce Clearance 
			Policy 
			Addressable Standard | 
			164.308(a)(3) | 
			Implement procedures to determine that the access of a workforce member to ePHI is appropriate. | 
		
		
			| 23 | 
			Termination Policy 
			Addressable Standard | 
			164.308(a)(3) | 
			Implement procedures for terminating access to ePHI when the employment ends or as required by (a)(3)(ii)(B) of this section. | 
		
		
			| 24 | 
			Access Authorization 
			Addressable Standard | 
			164.308(a)(4) | 
			Implement policies and procedures for granting access to ePHI, for workstations, transactions, programs, processes, or other mechanisms. | 
		
		
			| 25 | 
			Access Establishment 
			and Modification 
			Addressable Standard | 
			164.308(a)(4) | 
			Implement P&Ps, based on Access Authorization policies, to establish, document, review, and modify user's rights of access to workstations, transactions, programs, or processes. | 
		
		
			| 26 | 
			Security Reminders 
			Addressable Standard | 
			164.308(a)(5) | 
			Implement periodic reminders of security and information safety best practices. | 
		
		
			| 27 | 
			Protection from 
			Malicious Software 
			Addressable Standard | 
			164.308(a)(5) | 
			Implement Procedures for guarding against, detecting, and reporting malicious software. | 
		
		
			| 28 | 
			Log-in Monitoring 
			Addressable Standard | 
			164.308(a)(5) | 
			Implement Procedures for monitoring and reporting log-in attempts and discrepancies. | 
		
		
			| 29 | 
			Password Management 
			Addressable Standard | 
			164.308(a)(5) | 
			Implement Procedures for creating, changing, and safeguarding appropriate passwords. | 
		
		
			| 30 | 
			Security Incident Policy 
			Required Standard | 
			164.308(a)(6) 
			164.400 to 
			164.414 | 
			Identify and respond to suspected or known security incidents. Mitigate harmful effects. Document security incidents and their outcomes. | 
		
		
			| 31 | 
			Data Backup Policy 
			Required Standard | 
			164.308(a)(7) | 
			Establish and implement procedures to create and maintain retrievable, exact copies of ePHI during unexpected negative events. | 
		
		
			| 32 | 
			Disaster Recovery Policy 
			Required Standard | 
			164.308(a)(7) | 
			Establish (and implement as needed) procedures to restore any loss of data. | 
		
		
			| 33 | 
			Emergency Mode 
			Operation Policy 
			Required Standard | 
			164.308(a)(7) | 
			Establish (and implement as needed) procedures to enable continuation of critical business processes for protection of ePHI while operating in emergency mode. | 
		
		
			| 34 | 
			Testing and Revision 
			Policy 
			Addressable Standard | 
			164.308(a)(7) | 
			Implement procedures for periodic testing and revision of contingency and emergency plans. | 
		
		
			| 35 | 
			Applications and Data 
			Criticality Analysis 
			Addressable Standard | 
			164.308(a)(7) | 
			Assess the relative criticality of specific applications and data in support of other contingency plan components. | 
		
		
			| 36 | 
			Evaluation Policy 
			Required Standard | 
			164.308(a)(8) | 
			Perform periodic technical & nontechnical evaluations, to establish how well security P&Ps meet the requirements of this subpart. | 
		
		
			| 37 | 
			Business Associates Policy 
			Required Standard | 
			164.308(b)(1) 
			164.410 
			164.502(e) 
			164.504(e) | 
			CE’s must obtain, and BA’s must provide, written satisfactory assurances that all ePHI and PHI will be appropriately safeguarded. | 
		
		
			| 38 | 
			Contingency Operations Policy 
			Addressable Standard | 
			164.310(a)(1-2) | 
			Establish (and implement as needed) procedures that allow facility access to support restoration of lost data in the event of an emergency. | 
		
		
			| 39 | 
			Facility Security Policy 
			Addressable Standard | 
			164.310(a)(1-2) | 
			Implement P&P’s to safeguard the facility and the equipment therein from unauthorized physical access, tampering, and theft. | 
		
		
			| 40 | 
			Access Control and 
			Validation Policy 
			Addressable Standard | 
			164.310(a)(1-2) | 
			Implement procedures to control and validate individual access to facilities based on role or function; including visitor control, and access control for software testing and revision. | 
		
		
			| 41 | 
			Maintenance Records 
			Addressable Standard | 
			164.310(a)(1-2) | 
			Implement P&Ps to document repairs and changes to physical elements of a facility related to security (hardware, walls, doors, locks, etc.). | 
		
		
			| 42 | 
			Workstation Use 
			Required Standard | 
			164.310(b-c) | 
			Implement P&Ps that specify the proper functions, procedures, and appropriate environments of workstations that access ePHI. | 
		
		
			| 43 | 
			Workstation Security 
			Required Standard | 
			164.310(b-c) | 
			Implement physical safeguards for all workstations that access ePHI, to restrict access to authorized users. | 
		
		
			| 44 | 
			Media Disposal & Disposition 
			Required Standard | 
			164.310(d)(1-2) | 
			Implement P&Ps to address the final disposition of ePHI, and/or the hardware or electronic media on which it is stored. | 
		
		
			| 45 | 
			Media Re-use 
			Required Standard | 
			164.310(d)(1-2) | 
			Implement procedures for removal of ePHI from electronic media before the media are made available for re-use. | 
		
		
			| 46 | 
			Hardware & Media 
			Accountability 
			Addressable Standard | 
			164.310(d)(1-2) | 
			Maintain records of the movements of hardware and electronic media, and any person responsible therefore. | 
		
		
			| 47 | 
			Data Backup and Storage 
			Addressable Standard | 
			164.310(d)(1-2) 
			164.308(a)(7) | 
			The Data Backup Plan defines what data is essential for continuity after damage or destruction of data, hardware, or software. Risk Analysis determines what to backup. | 
		
		
			| 48 | 
			Unique User Identification 
			Required Standard | 
			164.306 
			164.312(a)(1-2) | 
			Assign a unique name and/or number for identifying and tracking user identity. | 
		
		
			| 49 | 
			Emergency Access Policy 
			Required Standard | 
			164.104 
			164.306 
			164.312(a)(1) | 
			Establish (and implement as needed) procedures for obtaining necessary ePHI during an emergency. | 
		
		
			| 50 | 
			Automatic Logoff 
			Addressable Standard | 
			164.306 
			164.312(a)(1-2) | 
			Implement electronic procedures that terminate an electronic session after a predetermined time of inactivity. | 
		
		
			| 51 | 
			Encryption and Decryption 
			Addressable Standard | 
			164.312(a)(1-2) | 
			Implement an appropriate mechanism to encrypt and decrypt ePHI. | 
		
		
			| 52 | 
			Audit Controls 
			Required Standard | 
			164.312(b) | 
			Implement hardware, software, and/or procedural mechanisms that record and examine activity in information systems that contain or use ePHI. | 
		
		
			| 53 | 
			Integrity Controls Policy 
			Addressable Standard | 
			164.312(c)(1-2) | 
			Implement electronic mechanisms to corroborate that ePHI has not been altered or destroyed in an unauthorized manner. | 
		
		
			| 54 | 
			Person or Entity 
			Authentication 
			Required Standard | 
			164.312(d) | 
			Implement procedures to verify that a person or entity seeking access to ePHI is the one claimed. | 
		
		
			| 55 | 
			Transmission Security Policy 
			Addressable Standard | 
			164.312(e)(1) | 
			Implement security measures to ensure that electronically transmitted ePHI is not improperly modified without detection until disposed of. | 
		
		
			| 56 | 
			Mobile Device Policy 
			Optional Policy | 
			164.302-164.314 | 
			Governs the use in an entity of mobile devices that can access, use, transmit, or store ePHI. |