The Health Insurance Portability and Accountability Act (HIPAA) Security Rule establishes national standards to protect individuals’ electronic personal health information that is created, received, used, or maintained by a covered entity. The Security Rule requires appropriate administrative, physical and technical safeguards to ensure the confidentiality, integrity, and security of electronic protected health information.
What is disaster recovery under the HIPAA Security Rule?
Disaster recovery is part of the HIPAA Security Rule’s requirements under the administrative safeguards section. Disaster recovery refers to an organization’s ability to respond to emergency situations that damage systems containing electronic protected health information (ePHI) and to enable the continuation of critical business processes and protection of ePHI while operating in emergency mode.
The HIPAA disaster recovery requirements are intended to ensure entities can restore lost data and maintain operations after disruption. This helps prevent improper disclosure of protected health information that could occur during or after a disaster.
What must a HIPAA disaster recovery plan include?
Under the HIPAA Security Rule, covered entities and business associates must establish and implement procedures for responding to emergencies and other occurrences that damage systems containing ePHI. The disaster recovery plan must include:
- A data backup plan
- A disaster recovery plan
- Emergency mode operations plan
- Testing and revision procedures
- Applications and data criticality analysis
Specifically, the HIPAA disaster recovery plan must:
- Identify the critical business processes and IT systems and the resources needed to support those processes and systems.
- Establish, implement and maintain procedures to create and maintain retrievable exact copies of ePHI.
- Establish procedures to restore any loss of data.
- Establish procedures to enable continuation of critical business processes and protection of security of electronic protected health information while operating in emergency mode.
- Establish procedures for periodic testing and revision of contingency plans.
- Assess the relative criticality of specific applications and data.
- Conduct an annual technical and non-technical evaluation of the plan based on the covered entity or business associate’s changing business processes, operations, systems or facilities.
Data Backup Plan
The data backup plan outlines procedures to create and maintain retrievable exact copies of ePHI. This includes:
- A complete data backup of all ePHI.
- Partial backups of system components.
- Archival requirements.
- Creating backup media.
- Storing backup copies offsite.
- Encrypted backups where feasible.
Disaster Recovery Plan
The disaster recovery plan establishes procedures to restore any loss of data and includes:
- Emergency operating procedures.
- Implementation procedures.
- Restoration procedures.
- Roles and responsibilities.
Emergency Mode Operation Plan
The emergency mode operation plan enables continuation of critical business processes for protection of the security of ePHI while operating in emergency mode. This includes:
- Procedures for operating in emergency mode.
- Documenting deviations from normal procedures.
- Procedures for returning to normal operations.
Testing and Revision Procedures
Testing and revision procedures are in place to periodically test and revise the disaster recovery and emergency mode operation plans. Testing may include:
- Walkthrough or tabletop exercise.
- Checklist exercise.
- Simulation test.
- Parallel test.
- Cutover test.
- Full interruption test.
Application and Data Criticality Analysis
Covered entities must assess the relative criticality of specific applications and data to minimize the risk of data loss. This analysis considers:
- How critical various software applications and data are to continuing operations
- Staff and other resources needed to resume operations
- Hardware and system software needed to resume operations
- Data and application restoration priorities
- Costs associated with system and data unavailability
What are the key elements of a HIPAA disaster recovery plan?
The key elements that should be included in a HIPAA-compliant disaster recovery plan are:
- Emergency procedures: Detailed steps to assess the damage, protect people, facilities, data and hardware after a disaster. Establish roles/responsibilities and emergency decision making hierarchy.
- Recovery location: Identify and equip an alternate processing site to recover critical systems and data. This could include an off-site data center, cloud or hybrid model.
- Technology recovery: Steps to restore IT and telecommunications infrastructure quickly. Define system and networking requirements for the interim solution.
- Vital records security: Backup and protection methods to enable data and records recovery. Include backup retention policies.
- Maintenance procedures: Schedule and procedures to test the disaster recovery plan and staff training. Update plan as needed.
- Return to normal operations: Steps to return to the original or new permanent operational location(s).
What are some key disaster recovery best practices?
Some best practices for developing a disaster recovery plan include:
- Conduct a business impact analysis (BIA) to identify critical systems and acceptable downtime.
- Secure off-site backup storage and alternate processing sites.
- Encrypt backups and protect media from physical damage.
- Prioritize systems recovery based on criticality.
- Include cyber incident/breach response procedures.
- Develop a communication plan to notify staff, customers, partners, etc.
- Integrate disaster planning with business continuity and emergency response plans.
- Test the plan regularly through drills and exercises.
- Train staff on their roles and orient new hires.
- Review and update the plan annually at minimum.
What are the penalties for non-compliance with the HIPAA disaster recovery requirements?
The penalties for non-compliance with HIPAA disaster recovery requirements can include:
- Breach Notification: Failure to restore data or systems in a disaster may require breach notification if it is determined the security or privacy of PHI is compromised. Breaches affecting 500+ individuals must be reported.
- HIPAA Audit Program: Lack of an adequate disaster recovery plan may be flagged under the HHS audit program. Audits can lead to mandatory corrective action plans.
- Civil Monetary Penalties: HHS may impose civil monetary penalties up to $50,000 per violation for a disaster recovery violation, with a maximum annual penalty of $1.5 million per year.
- Criminal Penalties: HIPAA violations due to willful neglect such as failure to have and test a disaster recovery plan may be subject to criminal penalties of up to $250,000 in fines and up to 10 years imprisonment.
In addition to penalties, non-compliance with disaster recovery requirements also greatly elevates risks to ePHI confidentiality and integrity in the event of an incident. Insufficient data backups and recovery capabilities can lead to permanent data loss and disruption or total termination of operations.
How often should HIPAA disaster recovery plans be tested and updated?
HIPAA requires covered entities and business associates to periodically test and revise their disaster recovery and emergency mode operation plans. HHS does not define an exact timeline, but best practice is to conduct testing exercises and update plans at least annually. More frequent testing may be warranted depending on the risk assessment.
Types of disaster recovery testing include walkthroughs, tabletop exercises, checklists, simulations, parallel testing, and full cutover and interrupted testing. Plans should be updated after each test to incorporate lessons learned.
In addition to testing, disaster recovery plans should be reviewed and revised following any changes to the operating environment including technology, facilities, business processes, regulatory obligations and personnel changes that impact roles and responsibilities.
Can HIPAA disaster recovery be outsourced?
Yes, HIPAA covered entities and business associates can outsource components of their disaster recovery programs but still retain responsibility for compliance. Many organizations use third-party data centers, cloud service providers or disaster recovery firms to provide backup and alternate site facilities.
When outsourcing any aspect of disaster recovery, HIPAA still requires entities to conduct due diligence in selecting vendors and formally document oversight in a business associate agreement. Vendor policies, procedures and capabilities must be evaluated to ensure they align with the organization’s compliance obligations.
Hybrid disaster recovery models that maintain some on-site capabilities while outsourcing other components like cloud-based backup storage offer flexibility for many entities. However, organizations still need to test integration and interoperability across internal systems and external provider platforms when operating in emergency scenarios.
What are the differences between HIPAA disaster recovery and business continuity requirements?
HIPAA disaster recovery requirements focus on restoring electronic systems and protecting ePHI when technology infrastructure is damaged. Business continuity is broader and encompasses maintaining all critical operations during disruptions.
Business continuity planning involves keeping mission-critical functions up and running for any type of disruption like natural disasters, cyber incidents, supply chain interruptions, etc. It deals with challenges not only to IT systems and data, but also facilities, communications, staffing, utilities, equipment, supplies, transportation, third-party services, etc.
HIPAA disaster recovery and business continuity plans are complementary. Business continuity plans may incorporate disaster recovery policies and procedures for recovering data and systems. Effective continuity planning integrates contingency plans across multiple platforms, systems and applications.
The HIPAA Security Rule requires covered entities and business associates to have documented disaster recovery plans to restore data and operations in the event of damage or disruption to facilities or systems containing electronic protected health information.
Disaster recovery requirements include data backup plans, emergency mode operations procedures, testing protocols and an application/data criticality analysis. Organizations that fail to comply with HIPAA disaster recovery rules risk data loss, systems outages, regulatory penalties, breach notification costs and reputational harm following an incident.
Regular testing, updating and outsourcing arrangements with qualified vendors can all support HIPAA disaster recovery capabilities. But healthcare organizations must ensure overall compliance accountability remains in place as they plan for disasters and mitigate risks to ePHI security.