Contingency planning and backup safeguards

Availability is a HIPAA Security Rule obligation, not an IT preference. The contingency planning and backup safeguards requirement is your control set for proving that ePHI can be accessed, restored, and operated on during an outage, disaster, ransomware event, or facility disruption. The regulation-level expectation is straightforward: protect ePHI availability through backup, disaster recovery, and emergency operations planning. ¹

For a CCO or GRC lead, the fastest path is to translate that sentence into an auditable operating model: (1) identify every system and workflow that touches ePHI, (2) set recovery targets that match patient care and business needs, (3) implement backups and recovery runbooks that meet those targets, and (4) test and document results on a repeatable schedule.

This page focuses on requirement-level execution. It gives you a step-by-step build, what evidence to keep, common audit traps, and a practical 30/60/90 plan. If you manage third parties, treat this requirement as a shared-responsibility problem: many ePHI outages originate in vendors, hosted platforms, and managed service providers, and you still need proof that recovery will work.

Regulatory text

Regulatory excerpt (provided): “Protect ePHI availability through backup, disaster recovery, and emergency operations planning.” ¹

What an operator must do

• Backup: Maintain retrievable copies of ePHI (and the systems required to read it) so data can be restored after corruption, ransomware, accidental deletion, or infrastructure failure. ¹
• Disaster recovery: Maintain a documented approach to restore systems and data that support ePHI processing after a major disruption. ¹
• Emergency operations: Maintain a plan to keep critical ePHI-supported operations running during an emergency, even if you are in a degraded mode. ¹

Plain-English interpretation (what this requirement really demands)

You need to show that ePHI is available when needed and recoverable after disruption. Practically, “availability” becomes provable only when you can answer three questions with evidence:

1. What ePHI do we have, and where is it? (systems, databases, endpoints, SaaS, archives, backups, replicas, third parties)
2. How fast must it be recovered? (business-driven recovery objectives for clinical and operational workflows)
3. Have we demonstrated recovery? (restore tests, disaster recovery exercises, emergency operations drills, and tracked fixes)

A common compliance gap is relying on a general IT disaster recovery slide deck while missing key ePHI systems, identity dependencies, encryption keys, interface engines, or cloud configuration state required to actually restore operations.

Who it applies to

Entity scope

• Covered Entities and Business Associates handling ePHI. ¹

Operational scope (where this bites in practice)

• Any system that creates, receives, maintains, or transmits ePHI, including EHR/EMR platforms, imaging systems, patient portals, claims/billing, HR/occupational health records if they contain ePHI, and data warehouses with PHI fields.
• Identity and access systems needed to access ePHI (IdP/SSO, MFA, directory services).
• Infrastructure and configuration state required to run ePHI systems (virtualization, containers, IaC, network/security configs).
• Third parties that store/process ePHI (hosted EHR, cloud storage, managed backups, MSPs). Your plan must incorporate their recovery capabilities and your own procedures to continue operations.

What you actually need to do (step-by-step)

1) Establish scope and ownership

1. Name an accountable owner for contingency planning (often IT/Security) and a compliance owner for oversight (you/CCO/GRC). Document roles and escalation paths.
2. Build an ePHI system inventory that includes: system name, owner, environment, data types, dependency map, and third-party involvement. Tie this to your broader HIPAA Security Rule documentation. ¹

Operator tip: If you cannot list every location ePHI is stored, you cannot prove you back it up.

2) Define recovery targets that the business can defend

3. For each in-scope system/workflow, define:
   • Recovery Time Objective (RTO): how quickly the service must return.
   • Recovery Point Objective (RPO): how much data loss is tolerable.
4. Validate RTO/RPO with operations and clinical leadership and document approvals.

Keep the targets simple and tiered (critical, important, standard) to avoid an unmaintainable plan.

3) Implement backups that are actually recoverable

5. Design backup coverage for each ePHI data store and required configuration state (databases, file stores, object storage, SaaS exports where needed, encryption keys, configuration repositories). ¹
6. Set retention and immutability expectations appropriate to your threat model (ransomware is the usual driver). Document your rationale, even if technology constraints exist.
7. Control access to backups (role-based access, separate admin accounts, and logging). A backup that attackers can delete is not a safeguard.
8. Document restore procedures as runbooks: prerequisites, order of operations, responsible roles, and verification checks.

4) Build a disaster recovery plan (DRP) that matches dependencies

9. Map dependencies: identity systems, DNS, networking, interface engines, certificate services, endpoint management, key management, and third-party connectivity.
10. Define recovery sequence (what comes up first, what can wait).
11. Specify recovery environments (secondary site, cloud region, warm standby, vendor-hosted DR) and prerequisites to activate them.

5) Build an emergency operations plan (EOP) for “degraded mode”

12. Identify minimum necessary operations during an outage (patient intake, medication administration record access, critical communications).
13. Define manual workarounds and data reconciliation steps post-recovery (how paper notes or offline entries re-enter systems).
14. Align the EOP with incident response so your team knows when to switch from “restore” to “operate manually” and back. ¹

6) Test, document, fix, and retest

15. Test backup restores for representative systems and data sets; record results and evidence. ¹
16. Exercise DR and emergency operations plans with tabletop and technical tests; document gaps, owners, and due dates.
17. Track corrective actions to closure and retain proof of remediation.

If you want the shortest path to audit-ready evidence, standardize testing templates and store them in a single evidence repository. Daydream is often used here to keep the control narrative, test artifacts, and exceptions together so audits do not turn into a file hunt.

Required evidence and artifacts to retain

Maintain an “availability evidence pack” that you can hand to auditors:

• ePHI system inventory and data flow notes (what stores/processes ePHI, owners, dependencies).
• Backup policy/standard and configuration summaries (scope, frequency approach, retention approach, access controls).
• Disaster Recovery Plan and Emergency Operations Plan (versioned, approved, with roles and escalation).
• Restore test records (test date, system, method, success criteria, screenshots/logs, issues found, sign-off).
• DR exercise records (scenario, participants, decisions, results, action items).
• Corrective action tracker (issues, risk rating, owner, target date, closure evidence).
• Third-party documentation relevant to recovery (contract/SLA language, shared responsibility notes, vendor DR attestations, and your internal procedures for vendor outages).

Common exam/audit questions and hangups

Auditors commonly probe:

• “Show me you can restore.” They will ask for restore test artifacts, not only backup tool screenshots.
• Scope completeness: “How do you know all ePHI systems are covered?” Expect inventory-to-backup mapping questions.
• Third-party reliance: “If your EHR is hosted, what is your plan when the vendor is down?”
• Plan freshness: “When were these plans last reviewed, exercised, and updated?”
• Operational ownership: “Who declares disaster, who approves failover, who communicates to workforce and patients?”

Hangups usually appear where IT and compliance documentation diverge. If IT says “DR is handled,” but you cannot produce exercise notes and remediation records, the control will read as non-operational.

Frequent implementation mistakes (and how to avoid them)

1. Mistake: Backing up data but not the ability to run it.
   Fix: Include configs, keys, identity dependencies, and application artifacts in scope; test full restoration paths.

2. Mistake: Ignoring SaaS and third parties.
   Fix: Document the shared-responsibility model, include vendor outage runbooks, and store vendor recovery evidence with your plans.

3. Mistake: No proof of testing.
   Fix: Schedule recurring restore tests and tabletop exercises, and capture outcomes with consistent templates. ¹

4. Mistake: Plans exist but staff cannot execute.
   Fix: Assign named roles, run drills, and keep runbooks runnable (current screenshots, current tool names, current contacts).

5. Mistake: Treating emergency operations as an IT-only document.
   Fix: Build clinical/operations participation into the plan, especially for downtime workflows and reconciliation.

Enforcement context and risk implications

No public enforcement cases were provided in your source set for this requirement, so this guidance stays anchored to the HIPAA Security Rule text itself. ¹ Operationally, outages and failed recoveries create two immediate risk lanes: (1) unavailability of ePHI for care and operations, and (2) inability to prove compliance because testing and governance artifacts are missing.

Practical 30/60/90-day execution plan

Days 0–30: Make scope real and close the biggest unknowns

• Build/validate the ePHI system inventory (include third parties and SaaS).
• Assign RTO/RPO tiers and get business sign-off.
• Document current-state backup coverage mapping: system → backup method → restore owner.
• Draft or refresh DRP and EOP outlines with named roles and escalation.

Days 31–60: Prove restore capability

• Run restore tests for highest-criticality systems; capture logs/screenshots and success criteria.
• Run at least one tabletop DR exercise and one emergency operations downtime drill; log action items.
• Implement backup access controls and logging review expectations.
• Create a corrective action tracker and drive high-risk fixes.

Days 61–90: Operationalize and make it repeatable

• Expand restore testing to remaining tiers; standardize templates.
• Update plans based on test outcomes; re-approve versions.
• Add third-party recovery procedures (contact paths, vendor status checks, contractual hooks, internal comms).
• Centralize evidence (plans, tests, approvals, exceptions). Daydream can serve as the system of record for control narratives and audit-ready artifacts across teams.

Frequently Asked Questions

Do we have to test restores, or is “we back up nightly” enough?

You need evidence that ePHI can be restored, which typically means documented restore testing and documented outcomes. Keep proof that the restore worked and that you addressed issues found. ¹

Our EHR vendor handles backups. What is our responsibility?

You still need documented procedures showing how your organization maintains ePHI availability during vendor downtime and how you validate the vendor’s recovery commitments. Treat the vendor as part of your contingency plan scope, not an exemption.

What should be in an emergency operations plan versus a disaster recovery plan?

DR focuses on restoring systems and data after disruption; emergency operations focuses on continuing critical workflows during the disruption, including manual processes and reconciliation steps. Both are part of protecting ePHI availability. ¹

How do we handle backups for SaaS systems that don’t offer traditional backups?

Document the approach you use to maintain retrievable ePHI (exports, vendor-provided recovery, or alternative controls), and test the recovery path you control. Retain evidence that the approach works in practice.

What evidence is most persuasive in an audit?

Restore test records with objective proof (logs/screenshots), signed exercise summaries, versioned plans with approvals, and a corrective action trail from findings to closure. Audits go faster when evidence is centralized and consistently formatted.

We have a DR document. Why do auditors still flag availability?

Common reasons are missing scope (not all ePHI systems covered), stale plans, no testing evidence, and no remediation tracking. Your artifacts must show the plan operates, not only that it exists. ¹

Related compliance topics

• 2025 SEC Marketing Rule Examination Focus Areas
• Access and identity controls
• Access Control (AC)
• Access control and identity discipline
• Access control lifecycle management

Footnotes

1. HIPAA Security Rule (45 CFR Part 164 Subpart C)