Hipaa/Hitech Privacy Security Checklist Self Assessment Instructions

Transcription

Note: The sample documents provided to the audience do not reflect ONC guidance. Instead, they areprovided by West Virginia RHITEC. These documents are for reference only.HIPAA/HITECH PRIVACY & SECURITY CHECKLISTSELF ASSESSMENT INSTRUCTIONSThank you for taking the time to fill out the privacy & security checklist. Once completed, this checklistwill help us get a better understanding of where we can better assist you. Below you will find someacronyms that are shown throughout the checklist as well as some brief instructions for completing ational Institute of Standards and TechnologyFederal Information Process StandardsProtected Health InformationElectronic Protected Health InformationBusiness AssociateCovered EntityElectronic Health RecordHealth and Human ServicesInformation SystemInstructionsHIPAA SECURITY RULE - ADMINISTRATIVE ) REQUIRED, (A) ADDRESSABLESecurity Management Process: Implement policies andprocedures to prevent, detect, contain, and correct securityviolations.43Has a Risk Analysis been completed in accordance with NISTGuidelines? (R)51 - The HIPAA Security Rule specifies a list of required or addressable safeguards. If an (R) is shown afterthe safeguard then implementation of that safeguard is required. If an (A) is shown then the safeguard mustbe assessed to whether or not it is reasonable and appropriate safeguard in your environment. If notimplemented, then it’s required to document the reason why and also implement an equivalent alternativesafeguard if reasonable and appropriate.2 – The reference refers to the C.F.R. (Code of Federal Regulations) that maps to the requirement orsafeguard to the specific regulation.3 – This field is the requirement or safeguard that is being evaluated. If shown in bold, then specifying astatus for that particular is not necessary since it’s an overview of the following rows to be evaluated.4 – For any of the highlighted fields, a status is not required since that row is just an overview of thefollowing rows to be evaluated.5 – This field is to specify the status of the requirement or safeguard. Please specify the following: N/A,Complete, In Progress, Not Complete, or Unknown. Please feel free to add any additional comments to thefield or on a separate sheet of paper.

Note: The sample documents provided to the audience do not reflect ONC guidance. Instead, they areprovided by West Virginia RHITEC. These documents are for reference only.HIPAA/HITECH PRIVACY & SECURITY CHECKLISTSELF ASSESSMENTHIPAA/HITECHREFERENCEHIPAA PRIVACY RULE / HIPAA SECURITY RULEHITECH ACTHIPAA PRIVACY 522Develop "minimum necessary" policies for:- Uses- Routine disclosures- Non-routine disclosures- Limit request to minimum necessary- Ability to rely on request for minimum necessaryDevelop polices for business associate (BA) relationships andamend business associate contracts or agreements:- Obtain satisfactory assurances in contract- Document sanctions for non-complianceLimit disclosures to those that are authorized by the client, orthat are required or allowed by the privacy regulations and statelaw.Develop and disseminate notice of privacy practice§164.524Develop policies for alternative means of communicationrequest.Develop policies for access to designated record set:§164.526- Providing access- Denying accessDevelop policies for amendment requests:§164.528§164.530- Accepting an amendment- Denying an amendment- Actions on notice of an amendment- DocumentationDevelop policies for accounting of disclosures.Implementation of Privacy Rule Administrative requirements,including:- Appoint a HIPAA privacy officer.- Training of workforce- Sanctions for non-compliance- Develop complaint policies.STATUSN/A, COMPLETE,IN PROGRESS, NOTCOMPLETE, UNKNOWN

Note: The sample documents provided to the audience do not reflect ONC guidance. Instead, they areprovided by West Virginia RHITEC. These documents are for reference only.- Develop anti-retaliation policies.- Policies and ProceduresHIPAA SECURITY RULE - ADMINISTRATIVE SAFEGUARDS(R) REQUIRED, (A) B)164.308(a)(4)(ii)(C)164.308(a)(5)(i)Security Management Process: Implement policies andprocedures to prevent, detect, contain, and correct securityviolations.Has a Risk Analysis been completed in accordance with NISTGuidelines? (R)Has the Risk Management process been completed inaccordance with NIST Guidelines? (R)Do you have formal sanctions against employees who fail tocomply with security policies and procedures? (R)Have you implemented procedures to regularly review recordsof IS activity such as audit logs, access reports, and securityincident tracking? (R)Assigned Security Responsibility: Identify the security officialwho is responsible for the development and implementation ofthe policies and procedures required by this subpart for theentity. (R)Workforce Security: Implement policies and procedures toensure that all members of its workforce have appropriateaccess to EPHI, as provided under paragraph (a)(4) of thissection, and to prevent those workforce members who donot have access under paragraph (a)(4) of this section fromobtaining access to electronic protected health information(EPHI).Have you implemented procedures for the authorization and/orsupervision of employees who work with EPHI or in locationswhere it might be accessed? (A)Have you implemented procedures to determine that the Accessof an employee to EPHI is appropriate? (A)Have you implemented procedures for terminating access toEPHI when an employee leaves you organization? (A)Information Access Management: Implement policies andprocedures for authorizing access to EPHI that areconsistent with the applicable requirements of subpart E ofthis part.If you are a clearinghouse that is part of a larger organization,have you implemented policies and procedures to protect EPHIfrom the larger organization? (A)Have you implemented policies and procedures for grantingaccess to EPHI, for example, through access to a workstation,transaction, program, or process? (A)Have you implemented policies and procedures that are basedupon your access authorization policies, established, document,review, and modify a user’s right of access to a workstation,transaction, program, or process? (A)Security Awareness and Training: Implement a security

Note: The sample documents provided to the audience do not reflect ONC guidance. Instead, they areprovided by West Virginia RHITEC. These documents are for reference .308(b)(1)164.308(b)(4)awareness and training program for all members of itsworkforce (including management).Do you provide periodic information security reminders? (A)Do you have policies and procedures for guarding against,detecting, and reporting malicious software? (A)Do you have procedures for monitoring login attempts andreporting discrepancies? (A)Do you have procedures for creating, changing, andsafeguarding passwords? (A)Security Incident Procedures: Implement policies andprocedures to address security incidents.Do you have procedures to identify and respond to suspected orknow security incidents; mitigate to the extent practicable,harmful effects of known security incidents; and documentincidents and their outcomes? (R)Contingency Plan: Establish (and implement as needed)policies and procedures for responding to an emergency orother occurrence (for example, fire, vandalism, systemfailure, and natural disaster) that damages systems thatcontain EPHI.Have you established and implemented procedures to create andmaintain retrievable exact copies of EPHI? (R)Have you established (and implemented as needed) proceduresto restore any loss of EPHI data that is stored electronically?(R)Have you established (and implemented as needed) proceduresto enable continuation of critical business processes and forprotection of EPHI while operating in the emergency mode? (R)Have you implemented procedures for periodic testing andrevision of contingency plans? (A)Have you assessed the relative criticality of specificapplications and data in support of other contingency plancomponents? (A)Have you established a plan for periodic technical and nontechnical evaluation of the standards under this rule in responseto environmental or operational changes affecting the securityof EPHI? (R)Business Associate Contracts and Other Arrangements: Acovered Entity (CE), in accordance with Sec. 164.306, maypermit a business associate to create, receive, maintain, ortransmit EPHI on the covered entity’s behalf only of the CEobtains satisfactory assurances, in accordance with Sec.164.314(a) that the business associate appropriatelysafeguard the information.Have you established written contracts or other arrangementswith your trading partners that documents satisfactoryassurances that the BA will appropriately safeguard theinformation? (R)

Note: The sample documents provided to the audience do not reflect ONC guidance. Instead, they areprovided by West Virginia RHITEC. These documents are for reference only.HIPAA SECURITY RULE - PHYSICAL SAFEGUARDS(R) REQUIRED, (A) y Access Controls: Implement policies andprocedures to limit physical access to its electronicinformation systems and the facility or facilities in whichthey are housed, while ensuring that properly authorizedaccess is allowed.Have you established (and implemented as needed) proceduresthat allow facility access in support of restoration of lost dataunder the disaster recovery plan and emergency modeoperations plan in the event of an emergency? (A)Have you implemented policies and procedures to safeguard thefacility and the equipment therein from unauthorized physicalaccess, tampering, and theft? (A)Have you implemented procedures to control and validate aperson’s access to facilities based on their role or function,including visitor control, and control of access to softwareprograms for testing and revision? (A)Have you implemented policies and procedures to documentrepairs and modifications to the physical components of afacility, which are related to security (for example, hardware,walls, doors, and locks)? (A)Have you implemented policies and procedures that specify theproper functions to be performed, the manner in which thosefunctions are to be performed, and the physical attributes of thesurroundings of a specific workstation or class of workstationthat can access EPHI? (R)Have you implemented physical safeguards for all workstationsthat access EPHI to restrict access to authorized users? (R)Device and Media Controls: Implement policies andprocedures that govern the receipt and removal ofhardware and electronic media that contain EPHI into andout of a facility, and the movement of these items within thefacility.Have you implemented policies and procedures to address finaldisposition of EPHI, and/or hardware or electronic media onwhich it is stored? (R)Have you implemented procedures for removal of EPHI fromelectronic media before the media are available for reuse? (R)Do you maintain a record of the movements of hardware andelectronic media and the person responsible for its movement?(A)Do you create a retrievable, exact copy of EPHI, when needed,before movement of equipment? (A)HIPAA SECURITY RULE - TECHNICALSAFEGUARDS(R) REQUIRED, (A) ADDRESSABLE164.312(a)(1)Access Controls: Implement technical policies andprocedures for electronic information systems that maintain

Note: The sample documents provided to the audience do not reflect ONC guidance. Instead, they areprovided by West Virginia RHITEC. These documents are for reference 4.312(e)(2)(ii)EPHI to allow access only to those persons or softwareprograms that have been granted access rights as specifiedin Sec. 164.308(a)(4).Have you assigned a unique name and/or number foridentifying and tracking user identity? (R)Have you established (and implemented as needed) proceduresfor obtaining for obtaining necessary EPHI during andemergency? (R)Have you implemented procedures that terminate an electronicsession after a predetermined time of inactivity? (A)Have you implemented a mechanism to encrypt and decryptEPHI? (A)Have you implemented Audit Controls, hardware, software,and/or procedural mechanisms that record and examine activityin information systems that contain or use EPHI? (R)Integrity: Implement policies and procedures to protectEPHI from improper alteration or destruction.Have you implemented electronic mechanisms to corroboratethat EPHI has not been altered or destroyed in an unauthorizedmanner? (A)Have you implemented Person or Entity Authenticationprocedures to verify that a person or entity seeking access EPHIis the one claimed? (R)Transmission Security: Implement technical securitymeasures to guard against unauthorized access to EPHI thatis being transmitted over an electronic communicationsnetwork.Have you implemented security measures to ensure thatelectronically transmitted EPHI is not improperly modifiedwithout detection until disposed of? (A)Have you implemented a mechanism to encrypt EPHI wheneverdeemed appropriate? (A)HITECHACT§13401§13402Application of security provisions and penalties to BusinessAssociates of Covered Entities; Annual guidance on securityprovisions.Are Business Associate Agreements updated appropriately?- The HITECH Act changes applicable to covered entities alsoapply to business associates for both privacy and security andneeds to be incorporated into the BA agreements.Notification in the case of breachProcess for notification to the following in the event of a breachof unsecured PHI:- Individuals- Media

Note: The sample documents provided to the audience do not reflect ONC guidance. Instead, they areprovided by West Virginia RHITEC. These documents are for reference only.- Secretary of HHS§13405§13405(c)Use of encryption in accordance with HHS guidance. Forexample, the use of FIPS 140-2 whole disk encryption asspecified in NIST 800-111.Restrictions on certain disclosures and sales of healthinformation; accounting of certain protected healthinformation disclosures; access to certain information inelectronic format.Process for Handling Individual’s Request to RestrictDisclosureLimit disclosure or use of PHI to minimum necessary toaccomplish purpose by, to the extent possible, limitinguse/disclosure to “limited data set”Accounting of certain protected health informationdisclosures required if CE uses electronic health record.If Covered Entities use electronic health record, CoveredEntities must include disclosures made through an EHR forpayment/treatment/health care operation on the accounting andthe individual can get an accounting ofpayment/treatment/health care operation disclosures madeduring past 3 years.Process to allow individual to obtain an accounting ofdisclosures made by Covered Entity & Business Associates oran accounting of disclosures by Covered Entity and a list ofBusiness Associates with contact information. BusinessAssociates must give individuals an accounting of PHIdisclosures.This checklist is to be used only to assist healthcare providers in HIPAA/HITECH awareness. It is theresponsibility of each provider to assess and comply with HIPAA and HITECH as is appropriate.WVMI and Quality Insights are not responsible for providers becomingHIPAA and HITECH compliant.References:1. IHS - HIPAA Security Checklist, fromhttp://hipaa.ihs.gov2. KaMMCO - Checklist for Covered Entities, fromhttp://www.kammco.com3. Alabama Medicaid Agency – Checklist for HIPAA Privacy, fromhttp://www.medicaid.state.al.us4. Patricia I. Carter (2010)HIPAA Compliance Handbook 2010 Edition

HIPAA/HITECH PRIVACY & SECURITY CHECKLIST SELF ASSESSMENT HIPAA/HITECH REFERENCE N/A, COMPLETE, HIPAA PRIVACY RULE / HIPAA SECURITY RULE HITECH ACT STATUS IN PROGRESS, NOT COMPLETE, UNKNOWN HIPAA PRIVACY RULE §164.502 §164.514 Develop "minimum necessary" policies for: - Uses - Routine disclosures - Non-routine disclosures