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HIPAA Compliance Checklist for IT Teams (PDF + Excel)

A HIPAA compliance checklist for IT teams: 76 controls mapped to 45 CFR, each with the evidence auditors ask for. Free PDF and Excel tracker.

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Atena Ladchartabi

Content writer, trio.so

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A HIPAA compliance checklist turns the HIPAA Security, Privacy and Breach Notification Rules into a list of jobs you can assign, finish and prove. This one has 76 controls in 12 areas. Each control cites its section of 45 CFR and lists the evidence an auditor will ask for. The PDF and Excel versions add an owner and a frequency for each one.

It is written for the people who carry most of the work: IT managers, sysadmins and MSPs supporting clinics, practices, health tech companies and business associates. The device and endpoint section goes further than most checklists, because that is the part IT actually configures.

Download the checklist as a printable PDF and an Excel tracker with a status dashboard, or work through it below.

Preview of the HIPAA compliance checklist PDF and Excel tracker
Preview of the HIPAA compliance checklist PDF and Excel tracker

TL;DR

In short

  • Start with a risk analysis that covers every system, laptop, phone and vendor that touches ePHI. It is the gap OCR has targeted in its recent settlements.
  • Encrypt every laptop and desktop, require passcodes on phones, and store the recovery keys centrally.
  • Sign a business associate agreement with every vendor before PHI reaches it.
  • Addressable does not mean optional. Do it, or document why not and what you do instead.
  • The 2025 Security Rule changes are still proposed, with final action listed for July 2027. They are still a sensible target.
  • Keep the evidence for 6 years. In an investigation, the record matters as much as the control.

What a HIPAA compliance checklist needs to cover

If you already know the three rules and the difference between required and addressable, skip to the checklist.

HIPAA applies to covered entities and their business associates. Covered entities are health plans, healthcare clearinghouses and providers who send standard transactions, such as claims, electronically. Business associates are vendors that create, receive, store or send PHI for them. That can include IT providers, MSPs and cloud services that have access to PHI. If you are not sure which you are, see our guide to HIPAA compliance for small business.

A complete checklist covers three rules:

  • The Security Rule (45 CFR 164.302 to 164.318) protects electronic PHI with administrative, physical and technical safeguards. For IT, this is most of the work.
  • The Privacy Rule (164.500 to 164.534) sets who may use or disclose PHI, including the minimum necessary standard and patient access rights.
  • The Breach Notification Rule (164.400 to 164.414) says who you must notify after a breach, and how fast.

Each Security Rule specification is either required or addressable. Required means you do it. Addressable means you do it if it is reasonable and appropriate, or you document why not and put an equivalent measure in place. It never means optional (164.306(d)).

There is no official HIPAA certification. HHS says it does not endorse or recognize private certifications. What protects you is a working program and the records to show it.

Start here: a 90-day plan

That is too many controls to start at once, so split them into three phases. The first 30 days cover the items regulators ask about first: the risk analysis, encryption, MFA, business associate agreements and offboarding.

The checklist in three phases: days 1 to 30, days 31 to 90, and ongoing
The checklist in three phases: days 1 to 30, days 31 to 90, and ongoing

In the Excel tracker, filter the Phase column to see each list. Give every item a named owner and a due date before you start.

The HIPAA compliance checklist, by area

Here is the full checklist. Start with the items marked "first 30 days". Required and addressable come from the rule text. Recommended items are not named in the rule, but they are how most teams meet the cited standard, often based on the HHS Cybersecurity Performance Goals. The PDF has the same list with checkboxes, owners and frequencies, and the Excel version adds status tracking.

76 controls across 12 areas, split into required, addressable and recommended
76 controls across 12 areas, split into required, addressable and recommended

Governance and scope (7 controls)

Someone has to own the program, and you have to know where ePHI lives before you can protect it.

IDWhat to do45 CFRTypeEvidence to keep
GOV-01Name a security official who owns the Security Rule program (first 30 days)164.308(a)(2)RequiredSigned appointment letter
GOV-02Name a privacy official and a contact person for privacy questions (first 30 days)164.530(a)RequiredAppointment letter; contact listed in your Notice of Privacy Practices
GOV-03Decide in writing whether you are a covered entity, a business associate, or both (first 30 days)160.103RequiredShort determination memo
GOV-04Map where ePHI is created, stored and sent: systems, devices, cloud apps and vendors (first 30 days)164.308(a)(1)(ii)(A)RequiredData flow map and system list
GOV-05Write security policies and procedures for every Security Rule standard164.316(a)RequiredPolicy set with version and approval dates
GOV-06Keep HIPAA documentation for 6 years from creation or last effective date164.316(b)(2)(i)RequiredRetention schedule; archive location
GOV-07Run a periodic technical and nontechnical evaluation of your safeguards164.308(a)(8)RequiredDated evaluation report

Risk analysis and management (4 controls)

Everything else builds on the risk analysis. OCR's Risk Analysis Initiative has made it a central issue in its settlements since late 2024. In September 2026, OCR settled with Ambry Genetics for $700,000 after a phishing attack affecting about 225,000 people, citing an inaccurate risk analysis, missing termination procedures and no unique user IDs. Make yours thorough, dated and tied to fixes. Our risk management plan template covers RISK-02.

IDWhat to do45 CFRTypeEvidence to keep
RISK-01Complete an accurate, thorough risk analysis that covers all ePHI, including laptops, phones, backups and vendors (first 30 days)164.308(a)(1)(ii)(A)RequiredDated risk analysis report with scope
RISK-02Turn every risk into a fix with an owner and a due date in a risk management plan (first 30 days)164.308(a)(1)(ii)(B)RequiredRisk register showing owners, dates and status
RISK-03Adopt a sanction policy for workforce members who break security rules, and apply it164.308(a)(1)(ii)(C)RequiredSanction policy; sanction records
RISK-04Review system activity regularly: audit logs, access reports and incident tracking164.308(a)(1)(ii)(D)RequiredReview log with reviewer and date

Workforce and training (6 controls)

Many incidents start with a person: a shared password, a phishing click, a laptop left in a car. Training and clear rules lower the odds.

IDWhat to do45 CFRTypeEvidence to keep
PEOPLE-01Authorize and supervise workforce members who work with ePHI164.308(a)(3)(ii)(A)AddressableAccess approval records
PEOPLE-02Check that each person's access fits their role before granting it (clearance)164.308(a)(3)(ii)(B)AddressableClearance step in onboarding records
PEOPLE-03Train every workforce member on security and privacy at hire and at least yearly (first 30 days)164.308(a)(5)(i); 164.530(b)RequiredTraining records and attestations
PEOPLE-04Send security reminders, such as phishing alerts and policy changes164.308(a)(5)(ii)(A)AddressableCopies of reminders sent
PEOPLE-05Monitor login attempts and report discrepancies164.308(a)(5)(ii)(C)AddressableFailed login report review
PEOPLE-06Set password rules for creating, changing and protecting passwords (first 30 days)164.308(a)(5)(ii)(D)AddressablePassword policy; enforced settings

Access and identity (9 controls)

Every person gets their own login, only the access their job needs, and nothing left behind when they leave. Pair this section with our IT offboarding checklist.

IDWhat to do45 CFRTypeEvidence to keep
ACCESS-01Give every person a unique user ID; remove shared and generic logins (first 30 days)164.312(a)(2)(i)RequiredUser list with no shared accounts
ACCESS-02Grant access by role, limited to the minimum necessary for the job164.308(a)(4)(ii)(B)AddressableRole-to-access matrix
ACCESS-03Use a documented process to create and change access (joiners and movers)164.308(a)(4)(ii)(C)AddressableAccess tickets with approvals
ACCESS-04Review who has access to each ePHI system and remove what is no longer needed164.308(a)(4)RecommendedSigned access review
ACCESS-05Verify the identity of every person or system before it can access ePHI (first 30 days)164.312(d)RequiredAuthentication settings per system
ACCESS-06Write an emergency access (break-glass) procedure for ePHI164.312(a)(2)(ii)RequiredProcedure and test record
ACCESS-07Remove all access the day someone leaves: SSO, apps outside SSO, shared accounts, devices, keys (first 30 days)164.308(a)(3)(ii)(C)AddressableOffboarding checklist with timestamps
ACCESS-08Keep admin accounts separate from daily user accountsHHS CPGRecommendedList of admin accounts
ACCESS-09Use multi-factor authentication for email, EHR, remote access and admin consoles (first 30 days)164.312(d); HHS CPGRecommendedMFA settings; MFA coverage report

Devices and endpoints: the HIPAA IT compliance checklist (17 controls)

This is the largest area, and the one most checklists skip. Laptops, desktops, phones and tablets hold or reach ePHI every day, and HHS lists loss or theft of equipment among the five main threats to healthcare organizations. These controls are the technical safeguards an IT team actually configures.

The eight core device controls for every laptop, desktop and phone with ePHI
The eight core device controls for every laptop, desktop and phone with ePHI
IDWhat to do45 CFRTypeEvidence to keep
DEV-01Keep a live inventory of every device that touches ePHI: owner, OS version, encryption, last check-in (first 30 days)164.310(d)(2)(iii)AddressableInventory export
DEV-02Encrypt every laptop and desktop (BitLocker, FileVault) and store recovery keys centrally (first 30 days)164.312(a)(2)(iv)AddressableEncryption status report; key escrow record
DEV-03Require a passcode on phones and tablets so built-in encryption is active (first 30 days)164.312(a)(2)(iv)AddressablePasscode compliance report
DEV-04Lock screens automatically after a set idle time, written in your policy (first 30 days)164.312(a)(2)(iii)AddressableScreen lock settings per platform
DEV-05Write a workstation use policy: which devices may access ePHI, where and how164.310(b)RequiredWorkstation use policy
DEV-06Physically protect workstations: positioning, privacy screens, locked rooms164.310(c)RequiredWalkthrough notes
DEV-07Patch operating systems and apps on a set timeline, fastest for critical issues (first 30 days)164.308(a)(1)(ii)(B)RecommendedPatch compliance report
DEV-08Run anti-malware on every endpoint and keep it current (first 30 days)164.308(a)(5)(ii)(B)AddressableAnti-malware coverage report
DEV-09Turn on host firewalls and block USB storage where it is not needed164.308(a)(1)(ii)(B)RecommendedConfiguration report
DEV-10Allow only approved apps on devices that hold ePHI164.308(a)(1)(ii)(B)RecommendedApproved app list
DEV-11Write BYOD rules: whether personal devices may touch ePHI, and the controls they need164.310(b); 164.308(a)(1)(ii)(B)RequiredBYOD policy; signed user agreements
DEV-12Have a lost or stolen device procedure: lock, locate, wipe, then assess for breach (first 30 days)164.308(a)(6)(ii)RequiredProcedure; lost device log
DEV-13Wipe or destroy devices and drives before disposal, and keep proof164.310(d)(2)(i)RequiredWipe record or destruction certificate
DEV-14Remove ePHI before a device is reissued to someone else164.310(d)(2)(ii)RequiredReissue record
DEV-15Back up ePHI before moving equipment164.310(d)(2)(iv)AddressableBackup confirmation
DEV-16Set a secure configuration baseline for each platform and check for drift164.308(a)(1)(ii)(B)RecommendedBaseline document; compliance report
DEV-17Replace unsupported operating systems, or isolate them with a documented exception164.308(a)(1)(ii)(B)RecommendedOS version report; exception log

Encryption is the control that changes the outcome of a loss. HHS breach guidance treats properly encrypted data as secured. If a device was encrypted to that standard and the key was not compromised, a lost laptop usually does not become a reportable breach. A login password is not encryption. Encryption also has to be on before the loss, so check status across the fleet, not one machine at a time.

PlatformWhat to turn onKeys and checks
WindowsBitLocker (Pro, Enterprise and Education editions; Home has only basic device encryption)Recovery key stored in your directory or device management tool
macOSFileVaultPersonal recovery key stored in your device management tool
iOS and iPadOSData protection, which turns on with a passcodeEnforce the passcode
AndroidEncryption, on by default on current devices, plus a screen lockEnforce the screen lock and a minimum OS version
LinuxLUKS full-disk encryption, set at installKeep the passphrase or key in your vault

If a device reports encrypted but there is no recovery key in your console, the key was probably never escrowed. Rotate it and store the new one before you need it.

Patching has no fixed deadline in today's rule; it sits under risk management and protection from malicious software. The proposed rule would set one: critical risks within 15 days, high risks within 30. That is a sensible target now. If patches keep missing certain machines, look first at medical imaging workstations or front-desk PCs excluded from your update rings, and at anything still running an unsupported OS. Isolate those and record the exception until they are replaced. Our guide to patch management covers the mechanics.

Personal phones can touch ePHI only if your risk analysis and BYOD policy allow it, and only with the same baseline: a passcode, a supported OS, and a way to remove work data. Write the rules down with our BYOD policy template, and see our guide to HIPAA rules for PHI on mobile devices.

Network and transmission (5 controls)

ePHI moving across networks needs the same care as ePHI at rest.

IDWhat to do45 CFRTypeEvidence to keep
NET-01Encrypt ePHI in transit: TLS for web and email, VPN for remote access (first 30 days)164.312(e)(2)(ii)AddressableTLS and VPN settings
NET-02Protect ePHI from being changed in transit without detection164.312(e)(2)(i)AddressableIntegrity control settings
NET-03Secure Wi-Fi with WPA2 or WPA3, and keep guests on a separate network164.308(a)(1)(ii)(B)RecommendedWi-Fi configuration
NET-04Segment the network: keep medical devices, guests and legacy systems apart164.308(a)(1)(ii)(B)RecommendedNetwork map with segments
NET-05Scan for vulnerabilities and run penetration tests164.308(a)(8)RecommendedScan and test reports

Audit logs and integrity (3 controls)

Logs answer the question an investigator asks first: who accessed what, and when.

IDWhat to do45 CFRTypeEvidence to keep
AUDIT-01Turn on audit logging in every system that holds ePHI: EHR, email, file storage, endpoints (first 30 days)164.312(b)RequiredLogging settings; sample log export
AUDIT-02Set how long logs are kept and protect them from editing164.312(b); 164.316(b)RequiredLog retention settings
AUDIT-03Protect ePHI from improper change or destruction, and be able to prove it164.312(c)(1)AddressableIntegrity controls description

Backup and contingency (6 controls)

Ransomware made this section urgent. You need backups you have actually restored, and a plan for running while systems are down. See our disaster recovery plan template.

IDWhat to do45 CFRTypeEvidence to keep
CONT-01Back up ePHI so you can restore an exact copy (first 30 days)164.308(a)(7)(ii)(A)RequiredBackup job reports
CONT-02Write a disaster recovery plan to restore lost data164.308(a)(7)(ii)(B)RequiredDisaster recovery plan
CONT-03Plan how to keep protecting ePHI while running in emergency mode164.308(a)(7)(ii)(C)RequiredEmergency mode plan
CONT-04Test restores and contingency plans, then fix what failed164.308(a)(7)(ii)(D)AddressableTest results with date
CONT-05Rank which applications and data matter most for recovery164.308(a)(7)(ii)(E)AddressableCriticality list
CONT-06Allow facility access to restore data during an emergency164.310(a)(2)(i)AddressableContingency access procedure

Facility security (3 controls)

Physical security still matters for server rooms, front desks and records storage.

IDWhat to do45 CFRTypeEvidence to keep
FAC-01Write a facility security plan for areas with ePHI systems164.310(a)(2)(ii)AddressableFacility security plan
FAC-02Control and validate physical access: badges, keys, visitor logs164.310(a)(2)(iii)AddressableBadge and visitor logs
FAC-03Record repairs to physical security: doors, locks, walls164.310(a)(2)(iv)AddressableMaintenance records

Vendors and business associates (4 controls)

If a vendor touches PHI, it needs a business associate agreement before the first record moves. That includes your EHR, email, cloud storage, billing service and IT provider.

IDWhat to do45 CFRTypeEvidence to keep
VEND-01List every vendor that creates, receives, stores or sends PHI for you (first 30 days)164.308(b)(1)RequiredVendor list
VEND-02Sign a business associate agreement with each one before PHI flows (first 30 days)164.308(b)(1); 164.502(e); 164.504(e)RequiredSigned BAAs
VEND-03If you are a business associate, sign BAAs with your own subcontractors164.308(b)(2); 164.314(a)RequiredSubcontractor BAAs
VEND-04Review each business associate's security safeguards164.308(b)(1)RecommendedVendor review notes or attestations

Incidents and breach notification (6 controls)

Decide the steps before you need them. Our data breach response plan template covers the full process.

IDWhat to do45 CFRTypeEvidence to keep
INC-01Write and test an incident response procedure: identify, respond, mitigate, document (first 30 days)164.308(a)(6)(ii)RequiredProcedure; incident log
INC-02Assess every possible breach using the four-factor risk assessment164.402RequiredCompleted risk assessments
INC-03Notify affected individuals without unreasonable delay, and no later than 60 days after discovery164.404RequiredCopies of notices and dates
INC-04Notify prominent media when a breach affects more than 500 residents of a state164.406RequiredMedia notice
INC-05Notify HHS: at the same time for 500 or more people; yearly log within 60 days of year end for fewer164.408RequiredHHS submission receipts
INC-06Business associates: report breaches to the covered entity within 60 days, or sooner if the BAA says so164.410RequiredNotice to covered entity

Privacy Rule essentials (6 controls)

The Privacy Rule is mostly a job for your privacy official, but IT supports several of these items.

IDWhat to do45 CFRTypeEvidence to keep
PRIV-01Confirm your Notice of Privacy Practices includes the changes due February 16, 2026, and post it in your office and on your website (first 30 days)164.520RequiredCurrent notice with date
PRIV-02Limit uses and disclosures of PHI to the minimum necessary164.502(b); 164.514(d)RequiredMinimum necessary policy
PRIV-03Answer patient access requests within 30 days (one 30-day extension allowed)164.524RequiredRequest log with dates
PRIV-04Run a complaints process, and never retaliate against people who complain164.530(d); 164.530(g)RequiredComplaint log
PRIV-05Get written authorization for uses that need it, such as marketing164.508RequiredSigned authorizations
PRIV-06Protect PHI in every form, including paper and conversations164.530(c)RequiredWalkthrough notes

Lost or stolen device: the 7-step runbook

When a device goes missing, the first hour matters. The 60-day notification clock starts when the loss is discovered. Agree on these steps in advance:

Seven steps for a lost or stolen device: report, lock and locate, wipe, check encryption, assess, notify if needed, log it
Seven steps for a lost or stolen device: report, lock and locate, wipe, check encryption, assess, notify if needed, log it
  1. Report. Staff tell IT the same day, with no penalty for reporting.
  2. Lock and locate. Send a remote lock and check the last known location.
  3. Wipe. If the device is not recovered quickly, wipe it.
  4. Check encryption. Confirm from your console records that it was encrypted, and that the key was not stored on or with the device.
  5. Assess. Run the four-factor breach risk assessment from 164.402: what PHI was involved, who may have it, whether it was actually acquired or viewed, and how far the risk has been reduced.
  6. Notify if needed. If you cannot show a low probability of compromise, notify without unreasonable delay, and no later than 60 days after discovery.
  7. Log it. Record the decision, even when it is "not a breach". The Excel tracker has a lost device log for this.
Breach notification deadlines for individuals, HHS and the media
Breach notification deadlines for individuals, HHS and the media

Notices go to affected individuals without unreasonable delay, and no later than 60 days after discovery. Breaches affecting 500 or more people are also reported to HHS at the same time. Smaller breaches go in a yearly log, due within 60 days of the end of the year. If more than 500 residents of one state are affected, prominent media outlets must be notified too.

What auditors ask for: the evidence pack

OCR investigators and outside auditors ask for records, not intentions. Keep these current and dated, and keep them for 6 years (164.316(b); 164.530(j) for Privacy Rule records).

ControlEvidenceSuggested refresh
Risk analysisDated report covering every system and device with ePHIYearly
Risk management planRisk register with owners, fixes and due datesQuarterly
Device encryptionEncryption status per device, with recovery keys escrowedMonthly
PatchingPatch compliance report by device and severityMonthly
Device inventoryEvery device with owner, OS version and last check-inQuarterly
Access reviewsSigned review of who can reach each ePHI systemQuarterly
Audit log reviewReview record with reviewer, date and findingsMonthly
OffboardingChecklist per leaver with timestampsEvery departure
TrainingAttendance records and signed attestationsYearly
Business associatesSigned BAA for every vendor on the vendor listYearly
BackupsBackup reports and the last restore testQuarterly
IncidentsIncident log and breach risk assessmentsEvery incident

Generate device reports on a schedule, not on request. A dated monthly encryption and patch report shows a control working over time. A screenshot taken the week before an audit shows only that week.

Preparing for an OCR audit or investigation

A HIPAA audit is a review by HHS's Office for Civil Rights (OCR) of whether a covered entity or business associate follows the Privacy, Security and Breach Notification Rules. Most organizations never get a random audit. They meet OCR through an investigation, after a complaint or a breach report. Either way, the request looks much the same.

How OCR actually reaches you

In 2024, OCR received 30,256 complaints and opened 730 compliance reviews. It started no audits that year, citing a lack of funding. It also investigates every reported breach affecting 500 or more people, and there were 663 of those in 2024. If you report a large breach, expect OCR to ask for your records.

The OCR audit program in 2026

  • 2016 to 2017: OCR audited 207 organizations. In its industry report, only 14% of covered entities substantially met the risk analysis requirement, and 94% failed on risk management.
  • November 2024: HHS's Inspector General found that those audits tested only 8 of 180 HIPAA requirements and no physical or technical safeguards. It recommended that future audits cover them.
  • 2024 to 2025: OCR announced a new round covering 50 covered entities and business associates, focused on the Security Rule provisions most relevant to hacking and ransomware. As of October 2026, OCR has not published the results.

The direction is clear: the next audits look at technical controls, which means the device and access evidence in this checklist.

What the request letter asks for

In the 2016 to 2017 audits, organizations had 10 business days to upload documents. OCR's desk audit guidance asked for the current risk analysis and the one before it, policies as they stood six years before the letter, records from the previous calendar year, and proof that staff could reach the documents and that they were reviewed. Investigation letters set their own deadlines, but they ask for the same kinds of records. The full list of what OCR can test is in its audit protocol.

The most common gap is not a missing policy. It is a missing record that the policy was followed.

HIPAA audit checklist: 15 things to have ready

The IDs point to the items in the checklist above, and in the PDF and Excel tracker.

#Have readyChecklist IDsWhat to have on file
1Name one person to handle OCR letters and track the response deadlineGOV-01, GOV-02Named security and privacy officials; a contact for OCR
2Your current risk analysis and the one before itRISK-01, GOV-04Both dated, both covering all ePHI: systems, devices, vendors
3The risk management plan, and proof the fixes happenedRISK-02Each risk with its fix, owner and date, plus the change records or reports
4Security, privacy and breach policies, with their historyGOV-05, GOV-06Version history going back 6 years
5Proof staff can reach the policies and that you review themGOV-06Folder permissions or intranet page, and a review log
6Your most recent evaluation of the safeguardsGOV-07Dated report, technical and nontechnical
7Training and security reminder records for the past yearPEOPLE-03, PEOPLE-04Attendance, attestations, reminder emails
8Vendor list with a signed BAA for eachVEND-01, VEND-02, VEND-03Including subcontractors if you are a business associate
9Access reviews, offboarding records and MFA coverageACCESS-04, ACCESS-07, ACCESS-09Signed reviews, leaver checklists with times, MFA enrollment report
10Audit log settings and log review recordsRISK-04, AUDIT-01, AUDIT-02Retention settings and a dated review log
11Device inventory and monthly encryption and patch reportsDEV-01, DEV-02, DEV-07Twelve months of dated reports, not one screenshot
12Backup reports and the last restore testCONT-01, CONT-04Result and date of the most recent test
13Incident log, breach risk assessments and notices for the past yearINC-01, INC-02, INC-03, INC-05Including incidents you decided were not breaches
14Notice of Privacy Practices and the patient access request logPRIV-01, PRIV-03Current NPP; requests with response dates
15Your recognized security practices fileGOV-05, RISK-01, DEV-01The framework you follow and 12 months of evidence it was in use

Get credit for recognized security practices

Since 2021, the law has required OCR to consider whether you had recognized security practices in place for the previous 12 months, such as the NIST Cybersecurity Framework or HHS's 405(d) practices, when it decides on fines and audit outcomes. OCR has said the practices must be "actively and consistently in use", so a policy adopted last month doesn't count. Keep a short file: which framework you follow, and dated evidence from the past year that you followed it. It is not a safe harbor, but OCR must weigh it.

The proposed 2025 HIPAA Security Rule: what would change

Status in October 2026: proposed, not law. HHS published the proposal on January 6, 2025. The current regulatory agenda lists it as a long-term action, with final action in July 2027. The rule in force today is the existing Security Rule.

The main changes in the proposal:

AreaWhat the proposal would require
Required vs addressableThe difference goes away; almost every specification becomes required
Asset inventory and network mapWritten, reviewed at least every 12 months
EncryptionePHI encrypted at rest and in transit, with limited exceptions
Multi-factor authenticationRequired, with limited exceptions
PatchingCritical risks within 15 days, high risks within 30 days
Vulnerability scans and pen testsScans at least every 6 months; pen test every 12 months
Backups and restoreBackups no more than 48 hours old; restore critical systems within 72 hours
Compliance auditAgainst every Security Rule standard, at least every 12 months
Access terminationNotify other regulated entities within 24 hours
Business associatesWritten verification of safeguards at least every 12 months

None of this is required yet, and the final rule may differ. Much of it matches what OCR already looks for after an incident. In the PDF and Excel tracker, 22 items are marked "Proposed": they already move you in this direction, so you can build toward it without waiting.

HIPAA penalties at a glance

Civil penalties depend on what the organization knew and how fast it fixed the problem. These are the per-violation ranges as adjusted on January 28, 2026, with a calendar-year cap of $2,190,294 for identical violations.

CulpabilityMinimumMaximum
Did not know$145$73,011
Reasonable cause$1,461$73,011
Willful neglect, corrected within 30 days$14,602$73,011
Willful neglect, not corrected$73,011$2,190,294

For real cases and how fines are set, see HIPAA violation fines and penalties.

Common mistakes that fail an audit

  • Treating addressable as optional. Every addressable item needs either the control or a written reason and an alternative.
  • A risk analysis that skips devices. Laptops, phones, backups and messaging apps belong in scope, not just the EHR.
  • Encryption with no stored recovery key. You lose the data if the user forgets the password, and you cannot prove the key was safe.
  • Offboarding that stops at single sign-on. Scheduling, texting and billing portals outside SSO are where former staff keep access.
  • Assuming a big vendor makes you compliant. A business associate agreement covers the vendor's part. Your configuration and your staff are still your part.
  • No record of the incident that was "not a breach". Document the assessment either way.

How trio.so helps with the device items

trio.so covers many of the device controls in this checklist from one console:

  • Encryption: enforce BitLocker on Windows and FileVault on Mac, and see encryption status for every device (DEV-02).
  • Passcodes and screen lock: set passcode rules and inactivity locks on Windows, macOS, iOS and Android (DEV-03, DEV-04, PEOPLE-06).
  • Patching: enforce OS updates on Windows, macOS, iOS and Android, and see vulnerability findings scored by CVSS, EPSS and CISA KEV (DEV-07).
  • Inventory: hardware, software and OS versions for every enrolled device, including Linux (DEV-01, DEV-17).
  • Lost devices: lock and locate lost Macs, iPhones and Android devices, and wipe company-owned devices remotely (DEV-12, DEV-14).
  • Offboarding: wipe or unenroll a departing employee's company device (ACCESS-07).
  • Configuration: firewall and USB rules on Mac and Windows, app allow and block lists, and compliance checks against a baseline (DEV-09, DEV-10, DEV-16).
  • Records: an admin event log that shows who changed what, and when, with export, plus device logs (RISK-04).

Compliance stays your organization's responsibility: the risk analysis, policies, training and agreements are yours to run. What trio.so gives you is control of the device settings this checklist asks for, plus the device reports that show they are working. Learn more about device management for healthcare and compliance automation.

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Sources. Last reviewed October 2026. This article is for information only and is not legal advice.

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Every organization today needs a solution to automate time-consuming tasks and strengthen security. Without the right tools, manual processes drain resources and leave gaps in protection. trio.so is designed to solve this problem, automating key tasks, boosting security, and ensuring compliance with ease.

Don't let inefficiencies hold you back.

Every organization today needs a solution to automate time-consuming tasks and strengthen security. Without the right tools, manual processes drain resources and leave gaps in protection. trio.so is designed to solve this problem, automating key tasks, boosting security, and ensuring compliance with ease.

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Frequently Asked Questions (FAQ)

Have questions? We've got answers. This section covers some of the most commonly asked questions related to this topic.

No. HHS does not certify organizations, people or products as HIPAA compliant, and it does not recognize private certifications. You show compliance through your risk analysis, policies, safeguards and records.

Encryption is an addressable specification today, so you must use it where reasonable or document an equivalent. For laptops that leave the building, few alternatives hold up, and encryption is what usually keeps a lost device from becoming a reportable breach. The proposed rule would make it required.

Usually not, if the encryption meets HHS guidance and the key was not compromised. You still need to assess the incident and document the decision.

Yes, if your risk analysis and BYOD policy allow it and the phone meets your controls. That means at least a passcode, a supported OS and a way to remove work data. Write the rules down and get users to sign them.

The current rule asks for an accurate, thorough analysis that you review periodically and whenever your environment changes. Many organizations do it yearly. The proposed rule would require a review at least every 12 months.

No. It was proposed in January 2025 and, as of October 2026, the regulatory agenda lists final action for July 2027. The existing Security Rule still applies.

The current rule sets no fixed deadline, but unpatched systems are a risk your risk analysis and risk management plan must address. The proposed rule would require critical fixes within 15 days and high-risk fixes within 30, which is a reasonable target now.

No. A device management tool covers many endpoint controls, such as encryption, passcodes, patching and remote wipe. The rest of the program, from the risk analysis to business associate agreements and training, is still yours.

A HIPAA audit or investigation letter usually asks for your current and previous risk analysis, the risk management plan, security and privacy policies with their history, training records, business associate agreements, and records showing your safeguards were in use, such as log reviews and device encryption reports. In the 2016-2017 audits, organizations had 10 business days to respond.

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