HIPAA Collaborative of Wisconsin Administrative Safeguard Scorecard Disclaimer This document is Copyright 2008 by the HIPAA Collaborative of Wisconsin (“HIPAA COW”). It may be freely redistributed in its entirety provided that this copyright notice is not removed. It may not be sold for profit or used in commercial documents without the written permission of the copyright holder. This document is provided “as is” without any express or implied warranty. This document is for educational purposes only and does not constitute legal advice. If you require legal advice, you should consult with an attorney. HIPAA COW has not yet addressed all state preemption issues related to this document. Therefore, this document may need to be modified in order to comply with Wisconsin law. Acknowledgements The development of this document was a consolidated effort by many people between 2005 and 2008. The following people have contributed to this document: Joan Benson Cathy Boerner Julie Coleman Mindy Daley Nancy Davis Claudia Egan Todd Fitzgerald Bonnie Goins Mary Koehler Chrisann Lemery Beth Malchetske Susan Manning Pete McCartney Allen Mundt Patti Pate Wayne Pierce Karl Radke Keisha Sabelko Holly Schlenvogt Jim Sehloff Kirsten Wild Effectiveness and Controls For each security standard and their related implementation specifications, each organization will need to establish security controls. These controls are established to reduce or eliminate vulnerabilities. NIST Special Publication 800-53, Recommended Security Controls for Federal Information Systems, is an excellent resource in helping you establish your baseline controls. (Refer to the reference section): The table below is an example of a control type and its related control levels: Control Type Physical Access Control and Validation Procedures None No control mechanisms used Related Control Levels Low Moderate All physical access points All physical access are controlled through the points are controlled use of cipher locks or key twenty-four hours per locks during working day, seven days per hours and are guarded or week through the use of locked during non-work entry devices such as hours. key card or biometrics. High All physical access points are controlled twenty-four hours per day, seven days per week through the use of guards or monitored alarms. Once the initial set of security controls are determined, they can be fine tuned and adjusted based on specific organizational policy and requirements documents, particular conditions and circumstances, known threat and vulnerability information, or tolerance for risk to the organization’s operations and assets. The controls should be phrased in the form of a question and measure the progress of effectively implementing them. We recommend a five level approach, which is defined as: Level 1 Level 2 Level 3 control objective documented in a security policy security controls documented as procedures procedures have been implemented 1. 3/20/2008 Level 4 Level 5 procedures and security controls are tested and reviewed procedures and security controls are fully integrated into a comprehensive program The following grid functions as a scorecard for the administrative safeguards in the security rule. Refer to the Physical Security Work Group Whitepaper for a scorecard relative to the HIPAA Physical Security requirements. How to Use the Grid Perhaps the most important thing about using the grid (scorecard) is that it is essentially an interactive checklist: as the user responds to one of the levels associated with a security control question - those questions listed under the Control Objectives and Techniques - they can indicate completion by checking the appropriate box at the intersection of the security control question and level. The user can also establish degrees of completeness for one or more of the levels as they see fit. This is not an all-inclusive list. For example, suppose we want to address the Emergency Mode Operation Plan implementation specification listed under the Contingency Plan HIPAA Security Standard, as seen below: HIPAA Security Standard Implementation Specification Control Objectives and Techniques Level 1 Policy Level 2 Procedures Level 3 Implemented Level 4 Tested Level 5 Integrated Comments 7. Contingency Plan – 164.308(a)(7) 7.3 Emergency Mode Operation Plan 7.3.1 Are resources supporting critical operations identified? 7.3.2 Have processing priorities been established and approved by management? Level 1-Write the Policy To begin, we need to establish an Contingency Plan Policy that addresses all of the Implementation Specifications listed under that standard: 7.1 Data Backup Plan, 7.2 Disaster Recovey Plan, 7.3 Emergency Mode Operations Plan, 7.4 Testing and Revision Procedure, 7.5 Applications and Data Criticality Analysis. Once the policy is complete, the form of which will differ from organization to organization, we can check-off (show completion by dating and/or color coding, or annotating in some fashion) the Level 1 Policy box and move on to Level 2. Level 2-Write the Procedures At this Level, there is one security control question prompting us to write procedures that relate to the Emergency Mode Operations Plan. Question 7.3.1 asks if resources are supporting critical operations identified in the plan. If not, then best practices according to NIST tells us that we should have a resource support process in place. Assuming we follow this recommendation, we need to write procedures on how we are going to do align those resources. Question 7.3.2 should be addressed in the same manner. Once these two control questions are completed, a Level 2 status will have been reached with respect to the Emergency Mode Operation Plan Implementation Specification under the Contingency Plan HIPAA Security Standard. Level 3-Implement the Procedures Achieving Level 3 status means implementing the policy and procedures established thus far for the Emergency Mode Operation Plan. Remember, both control questions need to be addressed for Level 3 status to be achieved. Level 4-Procedures and Security Controls are tested and reviewed A great policy and set of procedures related to Emergency Mode Operation Plan may have been written and implemented, but to reach Level 4 status, the policy and procedures need to be tested to see that they work. Be diligent here and make sure that everyone involved knows and understands their role as the plan is tested! Once done, check it off and move to Level 5. 2. 3/20/2008 Level 5-Procedures and Security Controls are fully integrated into a comprehensive program Addressing this Level begs questions like, “Are the measures we have created, implemented, and tested consistent with the overall information security policy and philosophy of the organization?” and “Does this control compliment other controls we have in place or is it inconsistent with them?” These are heady questions, but the idea is that effective security must be holistic. That is, information security strength is less about the individual the pieces and more about how well they fit together. Maintaining information security strength is a never-ending process, requiring ongoing assessments of system security controls and adjustments or changes to those controls as needed. The scorecard is a great tool for benchmarking, documenting, and tracking those adjustments and changes over time. There are few other things worth noting when following the scorecard. First, the methodology of the scorecard is based largely on the NIST Special Publication 800-26 Self Assessment Guide (see References listing at the end of this document for the URL). Be sure to review that document to gain greater understanding of the methodology. Second, many of the questions used in the scorecard come directly from NIST Special Publication 800-26. They are identifiable with superscripted numbers and are cross-referenced to 800-26 in the Footnotes section toward the end of this document. Note: as of March 2008 the NIST 800-26 publication is obsolete and is superseded by 800-53A. Finally, NIST intends for those using this process to do it in sequence. That is, policies should be written before procedures, policies and procedures should both be written before implementing the procedures, and so forth. It should be obvious as to why this is the case, but most of us have tried and failed to uphold tested procedures without a policy only to have someone come along and implement a “better” way, thereby leading to confusion, workarounds, and other assorted headaches. 2008 And Beyond: The Centers For Medicare & Medicaid Services (CMS) direction CMS has long recognized that the largest information store of Personal Health Information (PHI) is contained within the systems of those companies contracted by the government to process Medicare claims. As such, CMS has required stringent security requirements structured to the NIST requirements for “HIGH” criticality and sensitive systems. For the past several years, compliance has been evaluated using the level 1-5 scale specified by NIST, with the expectation that contractors attain at least a level 3 (implemented) to be compliant, and preferably to have some controls at level 4 (tested). However, for 2008 and beyond, Medicare contractors must conduct an annual evaluation indicating that 1/3 of the controls have been tested. For the controls failing the testing criteria specified in the NIST Special Publication 800-53A, corrective action plans must be submitted. In other words, the expectation is that all Medicare contractors will achieve level 4 testing over the next 3 years. Why is this important? Because over time, the Medicare security provisions tend to be viewed as the ‘defacto requirements’ for healthcare, and with the extension of HIPAA Security audits into the Healthcare/Hospital arena in 2008, it is advisable to pay attention to the expectation that in the future, it will no longer be acceptable for the security control to be at compliance level 3. The control will need to be independently tested by another party (internal/ external) to achieve level 4 compliance, which will become the future expectation. Savvy security professionals will plan for and integrate this testing process into the infrastructure when designing controls. 3. 3/20/2008 HIPAA Security Standard 1. Security Management Process – 164.308(a)(1) Implementation Specification 1.1 Risk Analysis 1.2 Risk Management Has each risk been addressed? Control Objectives and Techniques Level 1 Policy Level 2 Procedures Level 3 Implemented Level 4 Tested Level 5 Integrated Comments 1.1.1 Has an inventory of the components comprising the organization’s information systems been developed and maintained? 1.1.2 Are risk assessments performed and documented on a regular basis or whenever the system, facilities, or other conditions change?1 1.1.3 Has data been classified according to degree of sensitivity? 1.1.4 Have threat sources, both natural and manmade, been identified? 2 1.1.5 Has a list of known system flaws, vulnerabilities, weaknesses that could be exploited by the threat sources been developed and maintained current? 3 1.1.6 Has an analysis been conducted that determines whether the security requirements in place adequately mitigate vulnerabilities?4 1.1.7 Is the current system configuration documented, including links to other systems?5 1.2.1 Are final risk determinations and related management approvals documented and maintained on file? 6 1.2.2 Has a mission/business impact analysis been conducted? 7 1.2.3 Have additional controls been identified to sufficiently mitigate identified risks? 8 4. 3/20/2008 HIPAA Security Standard Implementation Specification 1.3 Sanction Policy 1.4 Information Systems Activity Review Control Objectives and Techniques Level 1 Policy Level 2 Procedures Level 3 Implemented Level 4 Tested Level 5 Integrated Comments 1.3.1 Are mechanisms in place for holding users responsible for their actions? 1.4.1 Are security alerts and incidents analyzed and remedial actions taken? 9 1.4.2 Is there an effective and timely process for reporting significant weakness and ensuring effective remedial actions taken? 10 1.4.3 Are intrusion detection tools installed on the system? 11 1.4.4 Are intrusion detection reports routinely reviewed and suspected incidents handled accordingly? 12 1.4.5 Is the system performance monitoring used to analyze system performance logs in real time to look for availability problems, including active attacks? 13 1.4.6 Is the activity involving access to and modification of sensitive or critical files logged, monitored, and possible security violations investigated? 14 1.4.7 Does the audit trail provide a trace of user actions? 15 1.4.8 Can the audit trail support after-the-fact investigations of how, when, and why normal operations ceased? 16 1.4.9 Are audit trails reviewed frequently? 17 1.4.10 Are automated tools used to review audit records in real time or near real time? 18 2. Assign Security Responsibility – 164.308(a)(2) 5. 3/20/2008 HIPAA Security Standard Implementation Specification Control Objectives and Techniques 2.1 Assign Security Responsibility 2.1.1 Has a person been identified that will be responsible for the development and implementation of HIPAA Security requirements? 3.1 Authorization and/or Supervision 3.1.1 Are duties separated to ensure least privilege access and individual accountability? 19 3.1.2 Are there documented job descriptions that accurately reflect assigned duties and responsibilities and that segregate duties? 20 3.1.3 Are mechanisms in place for holding users responsible for their actions? 21 3.1.4 Is there a process for requesting, establishing, issuing, and closing user accounts? 22 3.1.5 Are there processes in place for the authorization and/or supervision of workforce members, regardless of location, who work with ePHI? 3.2.1 Is appropriate background screening for assigned positions completed prior to granting access? Level 1 Policy Level 2 Procedures Level 3 Implemented Level 4 Tested Level 5 Integrated Comments 3. Workforce Security 164.308(a)(3) 3.2 Workforce Clearance Procedure 23 3.2.2 Are individuals authorized to bypass significant technical and operational controls screened prior to access and periodically thereafter? 24 3.2.3 Are confidentiality or security agreements required for employees assigned to work with sensitive information? 25 3.2.4 When controls cannot adequately protect the information, are individuals screened prior to access? 26 6. 3/20/2008 HIPAA Security Standard Implementation Specification 3.3 Termination Procedures Control Objectives and Techniques Level 1 Policy Level 2 Procedures Level 3 Implemented Level 4 Tested Level 5 Integrated Comments 3.2.5 Are there conditions for allowing system access prior to completion of screening? 27 3.3.1 Are hiring, transfer, and termination procedures established? 28 3.3.2 Is there a process for requesting, establishing, issuing, and closing user accounts? 29 4. Information Access Management – 164.308(a)(4) 4.1 Isolating Health Care Functions 4.1.1 Is the current system configuration documented, including links to other systems? 30 4.1.2 Have the security controls of the system and interconnected systems been reviewed? 31 4.1.3 Has management authorized interconnections to all systems (including systems owned and operated by another program, agency, organization, or contractor? 32 4.1.4 Is the operating system configured to prevent circumvention of the security software and application controls? 33 4.2 Access Authorization 4.3 Access Establishment and Modification 4.2.1 Are users individually authenticated via passwords, tokens, or other devices? 34 4.2.2 Is a current list maintained and approved of authorized users and their accesses? 35 4.3.1 Is there a process for requesting, establishing, modifying, and discontinuing user accesses? 7. 3/20/2008 HIPAA Security Standard Implementation Specification Control Objectives and Techniques Level 1 Policy Level 2 Procedures Level 3 Implemented Level 4 Tested Level 5 Integrated Comments 4.3.2 Do job descriptions include documentation on appropriate accesses to information and information systems? 5. Security Awareness and Training – 164.308(a)(5) 5.1 Security Reminders 5.2 Protection from Malicious Software 5.3 Log-in Monitoring 5.4 Password Management 5.1.1 Is there mandatory annual refresher training? 36 5.1.2 Are methods employed to make employees aware of security, i.e., posters, booklets? 37 5.2.1 Is malware detection and elimination installed and activated on all appropriate devices, including servers, workstations, and portable devices?38 5.2.2 Are malware signature files routinely updated? 39 5.2.3 Are malware scans automatic? 40 5.2.4 Are malware reports consistently reviewed and acted on in a timely manner? 5.3.1 Do the logical access controls restrict users to authorized transactions and functions? 41 5.3.2 Can the security controls detect unauthorized access attempts? 42 5.3.3 Is access monitored to identify apparent security violations and are such events investigated and documented? 43 5.4.1 Are users individually authenticated via passwords, tokens, or other devices? 44 8. 3/20/2008 HIPAA Security Standard Implementation Specification Control Objectives and Techniques Level 1 Policy Level 2 Procedures Level 3 Implemented Level 4 Tested Level 5 Integrated Comments 5.4.2 Are passwords changed at a time interval determined to be acceptable by the organization’s risk analysis? 45 5.4.4 Are passwords not displayed when entered? 47 5.4.5 Are there procedures in place for handling lost and compromised passwords? 48 5.4.7 Are passwords transmitted and stored using secure protocols/algorithms? 50 5.4.8 Are vendor-supplied passwords replaced immediately? 51 6. Security Incident Procedures – 164.308(a)(6) 6.1 Response and Reporting 6.1.1 Is there a capability to provide help to users when a security incident occurs in the systems? 52 6.1.2 Is a formal incident response capability available? 53 6.1.3 Is there a process for reporting incidents? 54 6.1.4 Are incidents monitored and tracked until resolved? 55 6.1.5 Are personnel trained to recognize and handle incidents? 56 6.1.6 Are alerts/advisories received and responded to? 57 6.1.7 Is there a process to modify incident handling procedures and control techniques after an incident occurs? 58 6.1.8 Is incident information and common vulnerabilities or threats shared with appropriate organizations? 59 6.1.9 Are security incidents documented, maintained, and 9. 3/20/2008 HIPAA Security Standard Implementation Specification Control Objectives and Techniques Level 1 Policy Level 2 Procedures Level 3 Implemented Level 4 Tested Level 5 Integrated Comments analyzed for trends? 7. Contingency Plan – 164.308(a)(7) 7.1 Data Backup Plan 7.2 Disaster Recovery Plan 7.1.1 Are critical data files and operations identified and the frequency of file backup documented? 60 7.2.1 Has a comprehensive contingency plan been developed and documented? 61 7.2.3 Are responsibilities for recovery assigned? 63 7.2.4 Are there detailed instructions for restoring operations? 64 7.2.5 Is there an alternate processing site; if so, is there a contract or interagency agreement in place? 65 7.2.6 Is the location of stored backups identified? 66 7.2.7 Are backup files created on a prescribed basis and rotated offsite often enough to avoid disruption if current files are damaged? 67 7.2.8 Is system and application documentation maintained at a secured location? 68 7.2.9 Are all system defaults reset after being restored from a backup? 69 7.2.10 Are the backup storage site and alternate site geographically removed from the primary site an physically protected? 70 7.2.11 Has the contingency plan been distributed to all appropriate personnel? 71 10. 3/20/2008 HIPAA Security Standard Implementation Specification 7.3 Emergency Mode Operation Plan 7.4 Testing and Revision Procedure 7.5 Applications and Data Criticality Analysis Control Objectives and Techniques Level 1 Policy Level 2 Procedures Level 3 Implemented Level 4 Tested Level 5 Integrated Comments 7.3.1 Are resources supporting critical operations identified? 72 7.3.2 Have processing priorities been established and approved by management? 73 7.4.1 Are tested contingency/ disaster recovery plans in place? 74 7.4.2 Is an up-to-date copy of the plan stored securely off-site? 75 7.4.3 Are employees trained in their roles and responsibilities? 76 7.4.4 Is the plan periodically tested and readjusted as appropriate? 77 7.5.1 Is there an up-to-date inventory of applications, with their assigned level of criticality and other key attributes? 8. Evaluation – 164.308(a)(8) 8.1 Evaluation 8.1.1 Have the technical and nontechnical security controls been reviewed periodically? 78 8.1.2 Have systems and network boundaries been subject to periodic reviews? 79 8.1.3 Has an independent review been performed when a significant change occurred? 80 8.1.4 Are routine self-assessments conducted? 81 8.1.5 Are tests and examinations of key controls routinely made, e.g., network scans, penetration testing, analyses of router and switch settings? 82 8.1.6 Are security alerts and incidents analyzed and remedial actions taken? 83 8.1.7 Is there an effective and timely process for reporting significant weakness and ensuring effective remedial action? 84 11. 3/20/2008 HIPAA Security Standard 9. Business Associate Contracts and Other Arrangement. Implementation Specification Control Objectives and Techniques 9.1 Written Contract and Other Arrangement 9.1.1 Are there written agreements with Business Associates regarding how PHI must be safeguarded in accordance with HIPAA? Level 1 Policy Level 2 Procedures Level 3 Implemented Level 4 Tested Level 5 Integrated Comments 12. 3/20/2008 Footnotes: Questions listed in the scorecard above with superscripted numbers come from NIST Special Publication 800-26. The cross-references to those questions in the 800-26 document are detailed below: 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 Page A-5, Risk Management, 1.1.2 Page A-6, Risk Management, 1.1.4 Ibid, 1.1.5 Ibid, 1.1.6 Page A-5, Risk Management, 1.1.1 Page A-6, Risk Management, 1.2.1 Ibid, 1.2.2 Ibid, 1.2.3 Page A-8, Review of Security Controls, 2.1.5 Ibid, 2.2.1 Page A-35, Data Integrity, 11.2.5 Ibid, 11.2.6 Ibid, 11.2.7 Page A-50, Audit Trails, 17.1 Ibid, 17.1.1 Ibid, 17.1.2 Page A-51, Audit Trails, 17.1.6 Ibid, 17.1.7 Page A-18, Personnel Security, 6.1 Ibid, 6.1.2 Page A-19, Personnel Security, 6.1.5 Ibid, 6.1.8 Ibid, 6.2 Ibid, 6.2.1 Ibid, 6.2.2 Page A-20, Personnel Security, 6.2.3 Ibid, 6.2.4 Page A-19, Personnel Security, 6.1.7 Ibid, 6.1.8 Page A-5, Risk Management, 1.1.1 Page A-7, Review of Security Controls, 2.1 Page A-15, Authorize Processing, 4.1.8 Page A-30, Hardware and Software Maintenance, 10.1.4 Page A-43, Identification and Authentication, 15.1 Ibid, 15.1.1 Page A-38, Security Awareness, Training, and Education, 13.1.3 Ibid, 13.1.4 Page A-34, Data Integrity, 11.1 Ibid, 11.1.1 Ibid, 11.1.2 Page A-46, Logical Access Control, 16.1 Ibid, 16.1.1 Page A-47, Logical Access Control, 16.10 13. 3/20/2008 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 61 62 63 64 65 66 67 68 69 70 71 72 73 74 75 76 77 78 79 80 81 82 83 84 Page A-43, Identification and Authentication, 15.1 Page A-44, Identification and Authentication, 15.1.6 Ibid, 15.1.7 Ibid, 15.1.9 Ibid, 15.1.10 Ibid, 15.1.11 Page A-45, Identification and Authentication, 15.1.12 Ibid, 15.1.13 Page A-40, Incident Response Capability, 14.1 Ibid, 14.1.1 Ibid, 14.1.2 Ibid, 14.1.3 Ibid, 14.1.4 Ibid, 14.1.5 Page A-41, Incident Response Capability, 14.1.6 Page A-41, Incident Response Capability, 14.2 Page A-27, Contingency Planning, 9.1.1 Ibid, 9.2 Ibid, 9.2.1 Ibid, 9.2.2 Page A-28, Contingency Planning, 9.2.3 Ibid, 9.2.4 Ibid, 9.2.5 Ibid, 9.2.6 Ibid, 9.2.7 Ibid, 9.2.8 Ibid, 9.2.9 Ibid, 9.2.10 Page A-27, Contingency Planning, 9.1.2 Ibid, 9.1.3 Page A-28, Contingency Planning, 9.3 Ibid, 9.3.1 Ibid, 9.3.2 Ibid, 9.3.3 Page A-7, Review of Security Controls, 2.1 Ibid, 2.1.1 Ibid, 2.1.2 Ibid, 2.1.3 Page A-8, Review of Security Controls, 2.1.4 Ibid, 2.1.5 Ibid, 2.2.1 References: 1. CMS Information Security Acceptable Risk Safeguards: http://www.cms.hhs.gov/it/security/docs/ars.pdf 2. All NIST Special Publications, whether published or in draft, may be accessed from this link: http://csrc.nist.gov/publications/index.html. 14. 3/20/2008 A. NIST Self Assessment Guide for Information Technology Systems, 800-26 November 2001 (now obsolete). B. NIST Risk Management Guide for Information Technology Systems, 800-30, July 2002. C. NIST Recommended Security Controls for Federal Information Systems, 800-53, February 2005. 15. 3/20/2008