© Eric C. Thompson 2020
E. C. ThompsonDesigning a HIPAA-Compliant Security Operations Centerhttps://doi.org/10.1007/978-1-4842-5608-4_2

2. HIPAA Security Rule and Cybersecurity Operations

Eric C. Thompson1 
(1)
Dekalb, IL, USA
 

Before jumping into specific safeguards of HIPAA and how security operations center (SOC) activities relate, some background may help put things in perspective. The Health Insurance Portability and Accountability Act (HIPAA) was enacted on August 21, 1996. HIPAA focused on health coverage during gaps when workers change jobs. The act provided early incentives for entities to adopt digital records.1 The Security Rule was implemented on April 21, 2005, focusing on electronic Protected Health Information (ePHI) stored digitally. Enforcement of HIPAA was granted to the Department of Health and Human Services (HHS) on March 16, 2006, under the Enforcement Rule. HHS had the authority to investigate complaints and levy fines for privacy violations. The Health Information Technology for Economic and Clinical Act (HITECH) of 2009 incentivized healthcare organizations for adopting digital medical records. These incentives were part of a program termed Meaningful Use. Finally, in 2013 the Final Omnibus Rule went into effect. It was at this point when news of proactive audit programs surfaced, more news about investigations by HHS after breaches and fines became mainstream news.

Detect and Respond

The NIST Cybersecurity Framework (CSF) and associated mapping to HIPAA Safeguards is the best way to develop cybersecurity operations in an environment responsible for electronic Protected Health Information (ePHI) and compliance with HIPAA. Specifically, the following functions found in the Detect and Respond functions are the focus:
  • Anomalies and Events (DE.AE): Anomalous activity is detected in a timely manner and the potential impact of events is understood.

  • Security Continuous Monitoring (DE.CM): The information system and assets are monitored at discrete intervals to identify cybersecurity events and verify the effectiveness of protective measures.

  • Detection Processes (DE.DP): Detection processes and procedures are maintained and tested to ensure timely and adequate awareness of anomalous events.

  • Response Planning (RS.RP): Response processes and procedures are executed and maintained to ensure timely response to detected cybersecurity events.

  • Communications (RS.CO): Response activities are coordinated with internal and external stakeholders, as appropriate, to include external support from law enforcement agencies.

  • Analysis (RS.AN): Analysis is conducted to ensure adequate response and support recovery activities.

  • Mitigation (RS.MI): Activities are performed to prevent expansion of an event, mitigate its effects, and eradicate the incident.

  • Improvements (RS.IM): Organizational response activities are improved by incorporating lessons learned from current and previous detection/response activities.

These categories and the applicable sub-categories are discussed in depth in the following paragraphs.

Logging Sources

Much of the Detection and Respond functions depend on logs generated by Protect function capabilities. To monitor the environment in a way that makes the Detect function effective requires logs. Without them, there is nothing to monitor, even the smallest of networks generate enough logs to make the monitoring process work:
  • Routers

  • Switches

  • Firewalls

  • IPS Systems

  • Web Proxy

These are just a few examples of protect devices critical to detection and response.

Information assets also produce valuable logging. Laptops and servers generate event logs useful to SOC analysts. Windows is the most common operating system in endpoints, although some environments may use various flavors of Linux or Unix. Each of these operating systems can generate significant amounts of log data.

Endpoints offer vast opportunities to log events of interest. Both Linux and Windows offer logging by default. Windows especially offers additional logging options important to analysts. Sysmon, short for System Monitor, is a Windows system service and device driver offering more robust details than default logging. A more detailed discussion on the importance of filtering out noisy logs appears in Chapter 5.

HIPAA Security Rule and Security Operations

The HIPAA Security Rule deals with patient information in electronic form. Therefore, it is mandatory that covered entities and business associates build security operations *programs designed to detect unauthorized activity and respond appropriately. HIPAA does not have specific safeguards requiring the use of threat intelligence. It does expect risk assessment and analysis to be complete and timely. This includes understanding and documenting the threats to the confidentiality, integrity, and availability of ePHI. HIPAA requires that entities know what vulnerabilities exist, consider reasonably anticipated threats, and implement security measures to reduce these risks to an acceptable level. Several safeguards address monitoring and detection requirements.

HIPAA Security Rule 45 C.F.R. Part 164

45 C.F.R. Part 164 Subpart C dictates the security standards for Protection of Electronic Protected Health Information (ePHI).2 It states in 164.302 that covered entities and business associates must comply with applicable standards, implementation specifications, and requirements with respect to ePHI.

Section 164.304 contains key definitions under the HIPAA Security Rule. Examples are outlined in Figure 2-1.
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Figure 2-1

Common definitions found in HIPAA 164.304

These definitions help when designing the security operations center/program, to avoid confusion regarding compliance with HIPAA requirements.

HIPAA Security Rule Safeguards and NIST CSF Detection and Response Controls

Each following section describes the full implementation specifications under the HIPAA Security Rule mapped to the Detect and Respond categories of the CSF. The goal is to describe the requirements under HIPAA and practical applications of cybersecurity controls designed to comply.

164.308(a)(1)(ii)(A) Risk analysis (Required)

Conduct an accurate and thorough assessment of the potential risks and vulnerabilities to the confidentiality, integrity, and availability of electronic protected health information held by the covered entity or business associate.

This safeguard was the focus of the book Building a HIPAA-Compliant Cybersecurity Program.3 This safeguard is often cited as lacking during breach investigations conducted by the Office for Civil Rights (OCR), the group within HHS enforcing compliance with HIPAA. The risk analysis must include all instances of ePHI located across the enterprise. It must also be comprehensive enough to include all risks to ePHI and include reasonably anticipated threats.4 When designing the security operations center, it is necessary to use the risk analysis as your guide. The assets storing, processing, and transmitting ePHI are identified during the risk analysis. Threats and vulnerabilities affecting the confidentiality, integrity, and availability of ePHI are also identified. These data points are key when designing security operations.

164.308(a)(1)(ii)(B) Risk management (Required)

Implement security measures sufficient to reduce risks and vulnerabilities to a reasonable and appropriate level to comply with § 164.306(a).

Entities must identify security measures meant to reduce residual risks to acceptable levels. For example, if weak passwords in an application can allow unauthorized users to gain access to the system, a security measure is identified to mitigate this risk. Identifying someone to review system access frequently to identify unusual or unauthorized logins is an example of a mitigating control.

164.308(a)(1)(ii)(D) Information system activity review (Required)

Implement procedures to regularly review records of information system activity, such as audit logs, access reports, and security incident tracking reports.

All systems generate audit logs. Some more than operations teams can possibly ingest and review. The objective of the Anomalies and Events category is the timely detection of events with an understanding of the potential impact to the environment. The Continuous Monitoring category focuses on monitoring for events and acts as the second layer of defense for the Protect category. This is a large category for security operations with eight sub-category control processes mapped to this safeguard:
  • DE.AE-1: A baseline of network operations and expected data flows for users and systems is established and managed.

  • DE.AE-3: Event data are aggregated and correlated from multiple sources and sensors.

  • DE.CM-1: The network is monitored to detect potential cybersecurity events.

  • DE.CM-3: Personnel activity is monitored to detect potential cybersecurity events.

  • DE.CM-4: Malicious code is detected.

  • DE.CM-5: Unauthorized mobile code is detected.

  • DE.CM-6: External service provider activity is monitored to detect potential cybersecurity events.

  • DE.CM-7: Monitoring for unauthorized personnel, connections, devices, and software is performed.

The first sub-category, DE.AE-1, expects entities to baseline what is normal within the IT environment and map expected data flows. If you are dealing with ePHI, this means understanding the flow of ePHI through IT systems. The team must also review the network architecture to identify key points where network traffic can be captured and logged. Ideally this visibility is comprehensive and does not duplicate logging in order to reduce the potential for noise. DE.AE-3 is usually fulfilled by implementing a Security Incident and Event Management (SIEM) solution. The control dictates gathering log data from all parts of the network and endpoints. These logs are then used by the SIEM operators for correlation. DE.CM-1 focuses on firewall, intrusion detection, and anything that captures network flow data or full packets to be employed. DE.CM-3 requires endpoint monitoring. This can be achieved by utilizing Windows logs or by placing another solution on the endpoint for monitoring. DE.CM-4 requires network and endpoint analysis tools to detect malware, and DE.CM-5 focuses on these tools detecting unauthorized mobile code. Mobile code refers to applets – an example includes programs written in code such as Java appearing on web pages. DE.CM-6 is required when service providers have connections into the network for support purposes. The entity needs visibility into these connections to confirm all activity conforms to the business agreement. DE.CM-7 requires entities to monitor everything on the network to detect the anomalies mentioned.

164.308(a)(2) Standard: Assigned security responsibility

Identify the security official who is responsible for the development and implementation of the policies and procedures required by this subpart for the covered entity or business associate.

The requirement of this safeguard is self-explanatory. Entities must appoint someone to own implementations designed to meet the HIPAA Security Rule. The NIST CSF control mapped to this safeguard goes beyond just having someone in charge of HIPAA control processes. This control focuses on having personnel designated for responding to security events and incidents:
  • RS.CO-1: Personnel know their roles and order of operations when a response is needed.

Some will be part of the initial response team, and others might be part of an extended team. Often, members of the information security team, IT operations, and IT compliance make up the initial response team. Key business owners, C-suite executives, and outside experts are common functions assigned to extended response teams. These individuals are engaged when events are escalated to incidents and breaches.

164.308(a)(5)(ii)(B) Protection from malicious software (Addressable)

Procedures for guarding against, detecting, and reporting malicious software.

This is an implementation specification identified as addressable. This does not mean it is not required. Addressable means that covered entities or business associates must meet this safeguard unless a documented reason why it is not applicable exists.

For this safeguard, it means that if a system did not have access to the Internet, then an entity may not need to implement safeguards to protect against malicious software:
  • DE.AE-3: Event data are aggregated and correlated from multiple sources and sensors.

  • DE.CM-1: The network is monitored to detect potential cybersecurity events.

  • DE.CM-4: Malicious code is detected.

  • DE.CM-5: Unauthorized mobile code is detected.

  • DE.CM-7: Monitoring for unauthorized personnel, connections, devices, and software is performed.

  • RS.CO-2: Events are reported consistent with established criteria.

  • RS.CO-3: Information is shared consistent with response plans.

  • RS.AN-1: Notifications from detection systems are investigated.

This safeguard is very similar to the information system activity review safeguard discussed earlier. The first five controls were covered in that section.

RS.CO-2 requires entities to report incidents based on criteria, such as the mandatory reporting required by HITECH. RS.CO-3 dictates sharing event-related information is shared based on the incident response plan. This includes sharing information internally with business leaders and sharing with others within the industry if appropriate and regulators or law enforcement. What is shared and with who depends on the incident response plan. RS.AN-1 requires a process to document the investigation and resolution of alerts generated by monitoring tools.

164.308(a)(5)(ii)(C) Log-in monitoring (Addressable)

Procedures for monitoring log-in attempts and reporting discrepancies.

Another addressable safeguard, this focuses on login monitoring. Covered entities and business associates are expected to gather and correlate events and logs, investigate notifications, and report these events to proper stakeholders:
  • DE.AE-3: Event data are aggregated and correlated from multiple sources and sensors.

  • DE.CM-1: The network is monitored to detect potential cybersecurity events.

  • DE.CM-3: Personnel activity is monitored to detect potential cybersecurity events.

  • DE.CM-7: Monitoring for unauthorized personnel, connections, devices, and software is performed.

  • RS.CO-2: Events are reported consistent with established criteria.

  • RS.AN-1: Notifications from detection systems are investigated.

No new NIST CSF controls are mapped to this safeguard. Details of these control activities are discussed earlier.

164.308(6)(i) Standard: Security incident procedures

Implement policies and procedures to address security incidents.

Incident response is a key program within the overall cybersecurity program and security operations. When notifications are raised by monitoring devices, a process for systematically reviewing, investigating, and escalating these notifications must be implemented:
  • DE.AE-2: Detected events are analyzed to understand attack targets and methods.

  • DE.AE-5: Incident alert thresholds are established.

  • RS.CO-4: Coordination with stakeholders occurs consistent with response plans.

To effectively implement these processes, risks must be understood. Assets identified during the risk analysis must be understood well enough to know what proper behavior is and what is not. In DE.AE-2, knowing which assets interact with ePHI is necessary. Incident alert thresholds are documented as a part of DE.AE-5. For example, failed logins are not concerning until they exceed a specific number and are performed by unusual end users, at unusual times, or from unusual locations. RS.CO-4 means that members of the business affected by any events related to the systems he or she is responsible for are communicated with during an investigation.

164.308(a)(6)(ii) Implementation specification: Response and reporting (Required)

Identify and respond to suspected or known security incidents; mitigate, to the extent practicable, harmful effects of security incidents that are known to the covered entity or business associate; and document security incidents and their outcomes.

This is an important safeguard. Responding to events; mitigating the impact; and reporting on events, incidents, and breaches are the foundation of incident response program and the anchor of security operations. After assessing threat intelligence, managing vulnerabilities, and monitoring the environment, the entity is left to respond to anything unusual found. These eleven controls represent a broad approach. Detection controls focus on operating capabilities sufficiently, and response controls focus on proper containment, eradication, and recovery. The controls outlined here assist entities in complying with this safeguard:
  • DE.AE-3: Event data are aggregated and correlated from multiple sources and sensors.

  • DE.AE-4: Impact of events is determined.

  • DE. DP-4: Event detection information is communicated to appropriate parties.

  • RS.RP-1: Response plan is executed during or after an event.

  • RS.CO-2: Events are reported consistent with established criteria.

  • RS.CO-3: Information is shared consistent with response plans.

  • RS.AN-1: Notifications from detection systems are investigated.

  • RS.AN-2: The impact of the incident is understood.

  • RS.AN-4: Incidents are categorized consistent with response plans.

  • RS.MI-1: Incidents are contained.

  • RS.MI-2: Incidents are mitigated.

  • RS.MI-3: Newly identified vulnerabilities are mitigated or documented as accepted risks.

There are several controls in this section not previously discussed. DE.AE-4 comes from the risk analysis. Documented impacts from that analysis let the analyst understand potential impacts of events. DE.DP-4 is important because alerts and notifications by monitoring systems should be shared with other teams. For instance, high rates of failed logins by a service account could mean a configuration was changed. The infrastructure team would want to look into such an event. RS.RP-1 requires the entity to invoke a response plan if an event is escalated. RS.AN-2 is the same as DE.AE-4. Incident response plans should document the types of data/assets important to the entity and how each type is categorized. Complying with RS.AN-4 means the incident response plan categorized accordingly. For example, ePHI events may be categorized as critical severity, credit cards as high severity, and corporate data as moderate severity. RS.MI1-2 are essential pieces to an incident response plan. Plans and the playbooks document how to contain and mitigate the outbreak of all types of incidents. RS.MI-3 keeps the incident response and vulnerability management plans up-to-date as new vulnerabilities are expected to be uncovered and evaluated.

164.308(a)(8) Standard: Evaluation

Perform a periodic technical and nontechnical evaluation, based initially upon the standards implemented under this rule and, subsequently, in response to environmental or operational changes affecting the security of electronic protected health information, that establishes the extent to which a covered entity’s or business associate’s security policies and procedures meet the requirements of this subpart.

This safeguard expects covered entities and business associates to test their environments. These tests can be technical or non-technical. Four controls focusing on collecting and aggregating data, monitoring the network, detection activities, and process improvement are mapped to this safeguard:
  • DE.AE-3: Event data are aggregated and correlated from multiple sources and sensors.

  • DE.CM-1: The network is monitored to detect potential cybersecurity events.

  • DE. DP-2: Detection activities comply with all applicable requirements.

  • DE. DP-5: Detection processes are continuously improved.

Evaluation here focuses on the detection and monitoring processes and finding improvement opportunities, DE.DP-5. A Purple Team assessment might pay dividends here. Using a Purple Team does not focus just on penetration testing by attackers, but helping the SOC team improve its ability to detect events of interest. This utilizes two teams, one acting as the attackers trying to find the trophies identified in the environment (Red Team) and another trying to detect the movements are used to test these controls (Blue Team). The assessment focuses on when, where, and how the attack was detected. Non-technical assessments could focus on assessing logging capabilities for gaps or assessing threat intelligence and alerting to confirm detection rules make sense. These assessments are built on fact finding, utilizing inquiry and observation to develop findings and recommendation reports. Consultants draw from experiences on other engagements to recommend leading practices seen across many entities. Security operations fundamentally complies with DE.CM-1 since it focuses on building continuous monitoring processes. Mapping the security operations processes to HIPAA gets compliance with the DE.DP-2 control.

164.312(b) b) Standard: Audit controls

Implement hardware, software, and/or procedural mechanisms that record and examine activity in information systems that contain or use electronic protected health information.

The following two controls lead the entity toward compliance with this safeguard. Details of what these controls contain are outlined earlier:
  • DE.AE-3: Event data are aggregated and correlated from multiple sources and sensors.

  • DE.CM-1: The network is monitored to detect potential cybersecurity events.

Entities need a SIEM to manage all the data available for security monitoring. Several methods should be used to monitor the network and endpoints. Chapter 5 provides the details for solutions meeting these requirements.

164.312(e)(2)(i) Integrity controls (Addressable)

Implement security measures to ensure that electronically transmitted electronic protected health information is not improperly modified without detection until disposed of.
  • DE.CM-1: The network is monitored to detect potential cybersecurity events.

This control process appeared in several of the safeguards discussed previously.

HIPAA expects covered entities and business associates to (document expectations for protecting patient information). The safeguards documented in this chapter point to cyber operation controls. References to these controls are found in the NIST Cybersecurity Framework (CSF) and Center for Internet Security (CIS) Top 20 controls.

To comply with HIPAA, specifically the Security Rule, covered entities and business associates must
  • Know and understand threats to electronic Protected Health Information

  • Identify and remediate vulnerabilities

  • Monitor the environment for anomalies and events of interest

  • Analyze and respond to events and anomalies appropriately based on impact to the environment

Conclusion

The scope of security operations related to HIPAA is significant. HIPAA requires entities in possession of ePHI to account for reasonably anticipated threats, monitor for and remediate vulnerabilities, and monitor the environment and respond appropriately. Mixing compliance objectives and security operations objectives works the same way as mapping compliance objectives to information security objectives. This is going about the process backward. First, get the security operations objectives designed to maximize the effectiveness of the program so that inappropriate actions can be detected and responded to. Then, map those processes to HIPAA. Any gaps in compliance can be addressed specifically at that point.

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