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The CISO Decision Brief

HIPAA Security Rule Readiness Self-Assessment

Rates readiness against the Security Rule items and returns the blocking gaps, in counts and with no score.

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Answer it online instead: How ready are we for HIPAA?About 25 minutes, free, and nothing is stored.

Format
Excel
Size
76 KB
Length
9 sheets
Version
1.1
Updated

What's inside

Preview

The workbook's sheets as you will receive them, with its example rows and the values its formulas calculate. Highlighted [[text]] is for you to replace; rows marked EXAMPLE are for you to delete. Wide sheets scroll sideways. The cover, document control and changelog sheets are in the file.

Instructions

How to use this workbook

StepWhat to do
1Before you start, decide your role under HIPAA with the HIPAA Applicability Assessment (P31-A02), and have counsel confirm it. Enter the role and the date of this assessment on the Results sheet.
2Assess again at the interval HR-30 sets: at least every 6 months, after any blocking gap is closed, and after a trigger.
3On the Assessment sheet, choose a readiness level for each item from the list. Read the item's 'Operating when' column first: an item is Operating only when it meets all of it and the records could be shown if asked for. When in doubt, choose the lower level.
4The 'Rests on' column names the standards and specifications (HS-xx) in the Security Rule Safeguard Register; the 'Records to look at' column names the records (EV-xx) in the HIPAA Documentation & Evidence Checklist.
5Record the evidence you looked at, or the fact that decides the level, in the evidence column. Open the document or the record; do not rely on what people say.
6Where an 'Operating when' text names a review interval (12 months), that interval is the pack's default and the Rule sets none. Six years, where named, is the Rule's retention period for documentation (164.316(b)(2)(i)).
7For every item below Operating, say what is missing, name one owner, and estimate the effort (Small, Medium, Large; the Results sheet says what each means). The Check column prompts for anything missing.
8Use Not applicable only on SC-02, OR-04, BR-03, the items written for one role (the 'Applies to' column), and only where that role is not yours. Give the reason in the evidence column; counsel confirms it. Every other item is a duty of every organisation the Rules cover: Not applicable on it is not accepted, it counts as no answer, and the result reads Incomplete.
9Read the Results sheet. A blocking gap is escalated at once (HR-29).
10Copy every gap into the HIPAA Gap & Remediation Tracker (P31-A08). The date of this assessment is the date the gap is raised; the tracker sets the due date. Keep a copy of each completed assessment with the records.

Legend

Yellow cells are inputs. Everything else is calculated or fixed — do not overwrite formulas.

EXAMPLERows marked EXAMPLE in the first column show how a completed row looks. Delete them before approval.

This document helps a security team see what the HIPAA Security Rule and the breach notification rules ask of an organisation like yours, and what it could show. It is not legal advice. It does not say that you are compliant with HIPAA or that you are certified, and the Rules provide no certificate of compliance. Whether HIPAA applies to your organisation, in which role, and what a breach or a contract requires are for counsel to confirm. The notification deadlines are in P09 (RD-17 to RD-20) and P18, and are not repeated here.

The readiness levels:

Not started: Nothing exists yet.

Planned: Owner and approach agreed; not yet in place.

In place: Documented and working, but incomplete, short of its own target, or with too little record for a supervisor to sample.

Operating: Working in full and meeting its own target, with records a supervisor could sample.

Not applicable: The duty does not apply to the entity. The reason must be recorded, and confirmed with counsel. It counts neither for nor against the result.

Blocking items. Every item marked Blocking rests on the Rule's own text: a standard or a required specification of the Security Rule, or the breach notification rules. A blocking item below In place is a blocking gap. An item about addressable specifications is blocking because the assessment of each is required, and a written reason is required where one is not implemented as written; the pack asks for a record of every decision. No one safeguard is required by this. The items that are not blocking (SC-01, GV-03, BR-04, RS-01, RS-02) are preconditions or practices that help you show the work.

The result. Not ready: at least one blocking item is below In place (a blocking gap). Ready, with actions: no blocking gap, but some items are below Operating. Ready: every item is Operating, or does not apply with the reason recorded; Not applicable can be chosen only on SC-02, OR-04 and BR-03, which are written for one role, and on any other item it counts as no answer. Incomplete: some item has no answer. The result is about your records against these items. It is not a finding about the law and it is never a score. "Ready" means every item is recorded as Operating: it does not mean HIPAA ready, and an item marked Not applicable is left out of the result, so confirm each one with counsel. Not applicable items count neither for nor against the result.

Gap priority, by exposure. Priority 1 (A required duty has nothing in place): a blocking item is Not started or Planned. Close within 30 days of the assessment. Priority 2 (A required duty is in place but cannot be shown): a blocking item is In place but not Operating: the records would not stand up if asked for. Close within 90 days of the assessment. Priority 3 (An improvement): a non-blocking item is below Operating. Close within 180 days of the assessment. These are the pack's own targets and the Rule sets none. The close-by date is the latest allowed; the tracker keeps an earlier date where a plan already set one.

The rules this workbook applies: HR-29 ("A blocking gap is escalated at once: the security official tells the executive sponsor, the gap goes on the tracker as Priority 1 with an owner and a date, and it is reported at the next management review until it is closed. The pack's deadlines are its own, not the Rule's.") and HR-30 ("The readiness self-assessment is repeated at least every [[6]] months, after any blocking gap is closed, and after a trigger: a new system or supplier that handles ePHI, a breach, a merger, or a change in the law. The interval is the pack's default, not the Rule's."). The other rules are in the pack's documents.

EXAMPLE: Acme Corp (EXAMPLE), a business associate of the clinics it serves, as at 30 Sep 2026. The Results sheet calculates Not ready from its answers (blocking gaps RA-04, OR-02, DC-02); the result is not typed.

Applies to. Most items are for everyone. 'Hybrid entities', 'Group health plans', 'Covered entities' are for organisations in that role; any other organisation marks the item Not applicable, with the reason.

Not covered here. The notification deadlines and who decides to notify (P09 RD-17 to RD-20 and the decision rights; P18-A09 and P18-A10). The Privacy Rule's own duties, which are the covered entity's counsel's. State laws and customer contracts. The proposed Security Rule changes, which are a proposal and are not applied. Anything about paper records.

Tailoring for a small organisation: every standard applies, and the Rule lets you choose measures that fit your size and risks (164.306(b)). One or two people may own most items; estimate effort in the weeks they really have.

Tailoring for IT run by a service provider: rate an item on what you can show, not on what the provider says. The owner is the person who manages the provider, and Operating needs the provider's records to be available to you. Add any customer-contract term as an item on the blank rows at the foot of the Assessment sheet.

Limitations: see the foot of the Results sheet.

Assessment

One row per readiness item. Yellow columns are yours; the columns to the right of Effort calculate. Rate each item against its 'Operating when' column.

ExampleItem IDAreaReadiness itemRests on (A03 standards and specifications)Applies toOperating whenRecords to look at (A07)Blocking?Readiness levelEvidence and facts (reason, if not applicable)What is missing (below Operating)Gap owner (one role)EffortBlocking gap?Gap priorityClose by (latest)CheckOrder (working)Blocking IDs so far (working)May be Not applicable (working)Level counted (working)
EXAMPLESC-01Role and scopeOur role under HIPAA is decided, recorded and confirmed160.102; 160.103; 164.105 (area basis)AllThe applicability assessment is complete, its answers and the result are recorded, counsel confirmed it, and it was reviewed in the last 12 months.NoOperatingApplicability assessment (A02) done in March: business associate. Counsel confirmed it in writing.NoNoneOKNoOperating
EXAMPLESC-02Role and scopeHealth care components are designated and the designation is kept160.102; 160.103; 164.105 (area basis)Hybrid entitiesA hybrid entity has a written designation of its health care components and keeps it for six years. Not applicable if the entity is not a hybrid entity.EV-26YesNot applicableNot a covered entity, so no health care components. Counsel confirmed.NoNoneOKYesNot applicable
EXAMPLESC-03Role and scopeWe know every place ePHI lives or movesHS-01.1AllThe ePHI inventory covers every system, device, backup, supplier and data flow, names the owner of each, and was reviewed in the last 12 months.YesIn placeInventory lists 31 systems and 9 data flows with owners. Contractor laptops and ticket attachments are missing.Add the contractor laptops and the ticketing tool's attachments to the inventory, with owners.Security officialSmallNoPriority 229 Dec 2026OK2006NoIn place
EXAMPLEGV-01GovernanceA security official is named in writingHS-02AllOne person is named in writing by the executive sponsor, with the date, and the name is in the policy.EV-03YesOperatingLetter from the chief technology officer names Max Okafor (EXAMPLE); the name is in the policy.NoNoneOKNoOperating
EXAMPLEGV-02GovernanceSecurity policies and procedures are written, approved and in forceHS-21, HS-22AllWritten policies and procedures cover every standard, are approved at the level P04 sets, and are available to the people who use them.EV-01YesOperatingPolicies for all 22 standards approved by the chief technology officer; current versions on the intranet.NoNoneOKNoOperating
EXAMPLEGV-03GovernanceLeaders approve the risk analysis and oversee the planHS-01AllThe executive sponsor approved the latest risk analysis and receives a report on the risk management plan at the interval the pack sets.NoIn placeThe chief technology officer signed the March risk analysis. The plan is reported only when a risk changes.Set a reporting interval for the risk management plan and put it on the management review agenda.Security officialSmallNoPriority 329 Mar 2027OK3009NoIn place
EXAMPLEGV-04GovernanceA sanction policy exists and is appliedHS-01.3AllThe policy is written and communicated, and the record shows it applied when it was needed.EV-07YesOperatingSanction policy in the handbook; two warnings last year, each with the policy step recorded.NoNoneOKNoOperating
EXAMPLERA-01Risk analysis and managementA risk analysis covers all ePHI, accurately and thoroughlyHS-01.1AllThe latest risk analysis follows A04, covers the whole inventory including suppliers, rates every risk on the P05 scale, and is signed by the security official.EV-04YesOperatingMarch risk analysis follows A04, covers both subcontractors, rates 8 risks on the P05 scale, signed by the security official.NoNoneOKNoOperating
EXAMPLERA-02Risk analysis and managementThe risk analysis is currentHS-01.1AllIt was reviewed in the last 12 months and after each trigger since, and every version is kept for six years.EV-05YesIn placeReviewed in March. The support console added in July is not in it yet.Add the support console to the risk analysis and record the trigger.Security officialSmallNoPriority 229 Dec 2026OK2012NoIn place
EXAMPLERA-03Risk analysis and managementA risk management plan reduces risks to a reasonable and appropriate levelHS-01.2AllEvery risk above appetite has a treatment, an owner and a date, progress is tracked in the gap tracker (A08), and accepted risks follow P05 RM-08.EV-06YesIn placeEach of the 8 risks has a treatment, owner and date, tracked in a spreadsheet, not yet in the gap tracker (A08).Move the plan's actions into the gap tracker (A08) so progress is tracked in one place.Security officialSmallNoPriority 229 Dec 2026OK2013NoIn place
EXAMPLERA-04Risk analysis and managementInformation system activity is reviewed regularlyHS-01.4AllAudit logs, access reports and incident reports are reviewed at the set interval by someone who does not administer the system, and the reviews are recorded.EV-08YesPlannedLogs are collected but nobody reviews them on a schedule. A weekly review is planned from next month.Start the weekly log review by someone who does not administer the systems, and record each review.Security officialMediumYesPriority 130 Oct 2026OK1014RA-04NoPlanned
EXAMPLEWS-01Workforce and operationsAccess is authorised, cleared and ended for the workforceHS-03AllProcedures for authorisation or supervision, clearance and termination are written and followed (P13), and the leaver records show access ended on time.EV-09YesIn placeJoiner and leaver steps are followed for staff (P13). Contractor accounts are not in the leaver feed (ER-04).Bring contractor accounts into the leaver feed and show it in the leaver records.HR leadSmallNoPriority 229 Dec 2026OK2015RA-04NoIn place
EXAMPLEWS-02Workforce and operationsAccess to ePHI is authorised by role and reviewedHS-04AllAccess follows minimum necessary roles (P07, P13, P14), is granted and changed through a recorded process, and is reviewed at the interval P07 sets. A clearinghouse that is part of a larger organisation isolates its ePHI from it.EV-10YesOperatingRole-based groups; changes by ticket; access review done in July with signed results (P07).NoNoneOKRA-04NoOperating
EXAMPLEWS-03Workforce and operationsEveryone in the workforce, including management, is trainedHS-05AllA training and reminder programme covers malicious software, log-in monitoring and passwords (P16), and the records show everyone, including management, was reached.EV-11YesOperatingAnnual course and monthly reminders (P16); records show all staff and the executive team completed it.NoNoneOKRA-04NoOperating
EXAMPLEWS-04Workforce and operationsSecurity incidents are identified, handled and documentedHS-06AllProcedures follow P09, every incident has a record with its outcome, and the harmful effects were reduced as far as practicable.EV-12YesOperatingIncident procedure follows P09; the last 6 events each have a record and the steps taken to reduce harm.NoNoneOKRA-04NoOperating
EXAMPLEWS-05Workforce and operationsBackups, recovery and emergency mode are plannedHS-07.1, HS-07.2, HS-07.3AllA data backup plan, a disaster recovery plan and an emergency mode operation plan exist and are current (P22, P23).EV-13YesOperatingBackup, disaster recovery and emergency mode plans approved in February (P22, P23).NoNoneOKRA-04NoOperating
EXAMPLEWS-06Workforce and operationsContingency plans are tested and the criticality of data is assessedHS-07.4, HS-07.5AllA test was run in the last 12 months and revised from its findings, and the applications and data criticality analysis is current. Where a specification was judged not reasonable and appropriate, the record says why.EV-14YesIn placeRestore test run in August with findings. Failover to the second region untested (ER-05); criticality analysis a year old.Test the failover to the second region; refresh the criticality analysis.HR leadSmallNoPriority 229 Dec 2026OK2020RA-04NoIn place
EXAMPLEWS-07Workforce and operationsAn evaluation was done and is repeatedHS-08AllA technical and non-technical evaluation was done against the standards, and repeated after the last change that called for one and at least every 12 months.EV-15YesIn placeEvaluation done in November 2025. The support console has not been evaluated since it was added.Evaluate the support console and record the trigger for the evaluation.HR leadSmallNoPriority 229 Dec 2026OK2021RA-04NoIn place
EXAMPLEOR-01Business associatesEvery business associate and subcontractor that can reach ePHI is under a written agreementHS-09, HS-19AllEach has a signed agreement with the Security Rule content (A05), made before ePHI was shared.EV-17YesIn placeThe hosting provider has a signed agreement. The ticketing tool has none (ER-07).Sign the ticketing tool's agreement, or stop using it for tickets that quote patient details.Vendor ownerSmallNoPriority 229 Dec 2026OK2022RA-04NoIn place
EXAMPLEOR-02Business associatesThe agreements' security terms were checkedHS-19AllEach agreement was checked against A05's terms before signature, and gaps were recorded and followed up.YesPlannedHosting agreement checked against A05: 2 terms missing (BT-04, BT-06), follow-up under way. Ticketing tool not checked.Close the 2 missing terms with the hosting provider; check the ticketing tool's terms against A05.Vendor ownerMediumYesPriority 130 Oct 2026OK1023RA-04, OR-02NoPlanned
EXAMPLEOR-03Business associatesThe register of business associates is completeHS-09AllEvery supplier and subcontractor that can reach ePHI is on the register, with the agreement, the owner and the date reviewed (P06).EV-16YesIn placeRegister lists both subcontractors with owner. The ticketing tool's review date is blank.Fill in the ticketing tool's review date.Vendor ownerSmallNoPriority 229 Dec 2026OK2024RA-04, OR-02NoIn place
EXAMPLEOR-04Business associatesPlan documents oblige the plan sponsor to safeguard ePHIHS-20Group health plansA group health plan's documents are amended as 164.314(b) asks. Not applicable if you are not a group health plan, and a plan that gives its sponsor only summary health information, enrolment status or information under an authorisation may fall outside 164.314(b): ask counsel.EV-18YesNot applicableNot a group health plan, so no plan sponsor. Counsel confirmed.NoNoneOKRA-04, OR-02YesNot applicable
EXAMPLEPH-01Physical safeguardsPhysical access to systems and facilities is controlledHS-10AllA facility security plan, access and validation procedures and maintenance records exist, and contingency operations are assessed.EV-19YesOperatingOffices have badge access with logs; the provider holds the data centres; facility plan and maintenance log kept.NoNoneOKRA-04, OR-02NoOperating
EXAMPLEPH-02Physical safeguardsWorkstation use and security are specified and in placeHS-11, HS-12AllWorkstation use is specified and every workstation that reaches ePHI has physical safeguards.EV-20YesOperatingWorkstation use policy signed by all staff; managed laptops lock automatically.NoNoneOKRA-04, OR-02NoOperating
EXAMPLEPH-03Physical safeguardsDevices and media are controlled, from receipt to disposalHS-13AllDisposal and media re-use are written and recorded, and the accountability and backup-before-move specifications are assessed.EV-21YesIn placeDisposal procedure written. Old laptops are wiped by staff with no record (ER-08).Record each wipe and keep the certificate.Facilities leadSmallNoPriority 229 Dec 2026OK2028RA-04, OR-02NoIn place
EXAMPLETE-01Technical safeguardsEvery user has a unique identity and emergency access is definedHS-14, HS-17AllNo shared accounts reach ePHI, an emergency access procedure exists and has been tested, and automatic logoff and encryption are assessed (P14). The identity of a person or entity seeking access is verified.EV-22YesIn placeUnique IDs for all staff; emergency access tested in June. Support console is single-factor (ER-06); 12 contractor laptops lack disk encryption (ER-01).Require multi-factor sign-in for the support console; encrypt the 12 contractor laptops.Security officialSmallNoPriority 229 Dec 2026OK2029RA-04, OR-02NoIn place
EXAMPLETE-02Technical safeguardsActivity in ePHI systems is recorded and can be examinedHS-15AllAudit controls are on for every system that holds ePHI, the records are protected, and the review (RA-04) uses them.EV-24YesOperatingAudit logging is on for the database, support console and hosting accounts; logs are write-protected.NoNoneOKRA-04, OR-02NoOperating
EXAMPLETE-03Technical safeguardsePHI is protected from alteration and in transitHS-16, HS-18AllIntegrity mechanisms and transmission security are in place, and encryption of ePHI in transit and at rest has been assessed with a recorded decision.EV-25YesIn placeTLS in transit; integrity checks on the database. Encryption of emailed exports is not decided (ER-02).Record the encryption decision for exports and move exports to a secure download link.Security officialSmallNoPriority 229 Dec 2026OK2031RA-04, OR-02NoIn place
EXAMPLEDC-01DocumentationDocumentation is kept six years, available and reviewedHS-22AllDocuments are retained for six years from creation or last effect, made available to those who use them, reviewed at least every 12 months, and the register shows the retention end date.EV-02, EV-29YesOperatingDocument register shows owner, version, approval, next review and the six-year end date; all reviewed this year.NoNoneOKRA-04, OR-02NoOperating
EXAMPLEDC-02DocumentationEvery addressable specification has a decision on recordHS-03, HS-04, HS-05, HS-07, HS-10, HS-13, HS-14, HS-16, HS-18AllEach addressable specification has an addressable decision record: implemented, an equivalent alternative, or not implemented with the reasons.EV-23YesPlannedA decision record exists for encryption only; the other 8 standards with addressable specifications have none.Write the addressable decision record for the 8 standards that lack one.Security officialMediumYesPriority 130 Oct 2026OK1033RA-04, OR-02, DC-02NoPlanned
EXAMPLEBR-01Breach readinessA breach assessment procedure is in place and used164.402; 164.404 to 164.414 (area basis)AllThe procedure follows A06, assessments are signed and kept, and the exclusions and the four factors are applied to each event.EV-27YesOperatingProcedure follows A06; the 3 events this year each have a signed assessment.NoNoneOKRA-04, OR-02, DC-02NoOperating
EXAMPLEBR-02Breach readinessNotification is ready to run on its clocks164.402; 164.404 to 164.414 (area basis)AllThe roles, the templates and the contacts for the notices exist (P18-A09, P18-A10), and the time of discovery is recorded for every incident (P09 IM-13).YesIn placeRoles and contacts named; templates drafted from P18-A10, not yet approved. Discovery time recorded (P09 IM-13).Approve the notice templates and test the contact list.Security officialSmallNoPriority 229 Dec 2026OK2035RA-04, OR-02, DC-02NoIn place
EXAMPLEBR-03Breach readinessSmaller breaches are logged for the later notice to the Secretary164.402; 164.404 to 164.414 (area basis)Covered entitiesBreaches below the threshold for the notice to the Secretary that goes with the notice to individuals (P09 RD-19, P18-A09) are logged as they are found so that the later notice can be made. Not applicable if you are a business associate only.EV-28YesNot applicableNot a covered entity. Smaller breaches go to the covered entity customer under the agreement. Counsel confirmed.NoNoneOKRA-04, OR-02, DC-02YesNot applicable
EXAMPLEBR-04Breach readinessThe treatment of secured PHI is recorded164.402; 164.404 to 164.414 (area basis)AllWhere an event involved encrypted or destroyed PHI, the record shows how the method meets HHS's guidance and that the key was not compromised.NoNot startedNo event has involved encrypted data, and no method for the record is written.Write down how the record of secured PHI is made, using HHS's guidance.Security officialSmallNoPriority 329 Mar 2027OK3037RA-04, OR-02, DC-02NoNot started
EXAMPLERS-01Beyond the minimumRecognised security practices have been in place for at least 12 months and can be shown42 U.S.C. 17941; 90 FR 898 (area basis)AllThe organisation chose recognised security practices, the record shows they were in place for at least the previous 12 months, and it can show them. This is not required by the Security Rule; it is something the Secretary must consider.EV-30NoPlannedA recognised framework is chosen and the plan to put its practices in place is agreed; the 12 months have not started.Put the practices in place, then keep the records for at least 12 months.Security officialSmallNoPriority 329 Mar 2027OK3038RA-04, OR-02, DC-02NoPlanned
EXAMPLERS-02Beyond the minimumThe proposed Security Rule changes are watched42 U.S.C. 17941; 90 FR 898 (area basis)AllSomeone is assigned to follow the status of the proposed rule and to report to the security official when a final rule is published.NoNot startedNobody is assigned to follow the proposed rule.Assign a person to follow the proposed rule and report to the security official.Security officialSmallNoPriority 329 Mar 2027OK3039RA-04, OR-02, DC-02NoNot started

Results

Results

The result, the blocking gaps, readiness by area and every gap in priority order, calculated from the Assessment sheet. Only the yellow settings are yours.

EXAMPLE: the example organisation's self-assessment. Clear the EXAMPLE column and the yellow answers to use your own.

Settings

Date of this assessment30 Sep 2026EXAMPLE: the example quarter end. Close-by dates count from it.
Months to the next assessment (HR-30)6The [[6]] in HR-30: the pack's default, not the Rule's.
Our role (from the P31-A02 result)Business associateFrom the HIPAA Applicability Assessment. EXAMPLE: the result for the example organisation. Counsel confirms the role.
Assessed by (role)EXAMPLE: Max Okafor (EXAMPLE), Head of Information Security, the security officialThe person who rated the items and checked the evidence.

The result

ResultNot readyNot ready: at least one blocking item is below In place (a blocking gap). Ready, with actions: no blocking gap, but some items are below Operating. Ready: every item is Operating, or does not apply with the reason recorded; Not applicable can be chosen only on SC-02, OR-04 and BR-03, which are written for one role, and on any other item it counts as no answer. Incomplete: some item has no answer. The result is about your records against these items. It is not a finding about the law and it is never a score. "Ready" means every item is recorded as Operating: it does not mean HIPAA ready, and an item marked Not applicable is left out of the result, so confirm each one with counsel.
In one lineBusiness associate. Not ready: 3 blocking gaps, 16 other items below Operating.
Blocking gaps3Each is a Priority 1 gap: listed first below, with its effort.
Blocking gaps, by item IDRA-04, OR-02, DC-02
Escalate (HR-29)At once: the security official tells the executive sponsor; each blocking gap goes on the tracker as Priority 1 with an owner and a date; report it at each management review until it is closed.
Next assessment due (HR-30)30 Mar 2027Or sooner: after a blocking gap is closed, a new system or supplier that handles ePHI, a breach, a merger or a change in the law.

Readiness by area

AreaBasis (45 CFR)ItemsOperatingIn placePlannedNot startedNot applicableNot assessedResult: at OperatingBlocking gaps
Role and scope160.102; 160.103; 164.10531100101 of 2 at Operating0
Governance164.308(a)(1), (a)(2); 164.316(a)43100003 of 4 at Operating0
Risk analysis and management164.308(a)(1)41210001 of 4 at Operating1
Workforce and operations164.308(a)(3) to (a)(8)74300004 of 7 at Operating0
Business associates164.308(b); 164.31440210100 of 3 at Operating1
Physical safeguards164.31032100002 of 3 at Operating0
Technical safeguards164.31231200001 of 3 at Operating0
Documentation164.306(d); 164.31621010001 of 2 at Operating1
Breach readiness164.402; 164.404 to 164.41441101101 of 3 at Operating0
Beyond the minimum42 U.S.C. 17941; 90 FR 89820011000 of 2 at Operating0
All areas361413423014 of 33 at Operating3
Read the counts, not a percentage: an item In place works but is incomplete or has too little record to show. Items without an Item ID are not counted; Not applicable items are left out of 'at Operating'.

Effort to close the gaps

EffortPriority 1 (blocking)Priority 2Priority 3All gapsWhat it means
Small012416Under [[2]] weeks of work, inside one team, within budget.
Medium3003[[2]] to [[8]] weeks, or two or more teams, within budget.
Large0000More than [[8]] weeks, or money the budget does not hold.
Not estimated0000Enter the effort on the Assessment sheet.
All gaps312419

Every gap, in priority order (copy into the gap tracker)

No.Item IDReadiness itemPriorityLevelWhat is missingOwnerEffortClose by (latest)Row
1RA-04Information system activity is reviewed regularlyPriority 1, blockingPlannedStart the weekly log review by someone who does not administer the systems, and record each review.Security officialMedium30 Oct 202611
2OR-02The agreements' security terms were checkedPriority 1, blockingPlannedClose the 2 missing terms with the hosting provider; check the ticketing tool's terms against A05.Vendor ownerMedium30 Oct 202620
3DC-02Every addressable specification has a decision on recordPriority 1, blockingPlannedWrite the addressable decision record for the 8 standards that lack one.Security officialMedium30 Oct 202630
4SC-03We know every place ePHI lives or movesPriority 2In placeAdd the contractor laptops and the ticketing tool's attachments to the inventory, with owners.Security officialSmall29 Dec 20263
5RA-02The risk analysis is currentPriority 2In placeAdd the support console to the risk analysis and record the trigger.Security officialSmall29 Dec 20269
6RA-03A risk management plan reduces risks to a reasonable and appropriate levelPriority 2In placeMove the plan's actions into the gap tracker (A08) so progress is tracked in one place.Security officialSmall29 Dec 202610
7WS-01Access is authorised, cleared and ended for the workforcePriority 2In placeBring contractor accounts into the leaver feed and show it in the leaver records.HR leadSmall29 Dec 202612
8WS-06Contingency plans are tested and the criticality of data is assessedPriority 2In placeTest the failover to the second region; refresh the criticality analysis.HR leadSmall29 Dec 202617
9WS-07An evaluation was done and is repeatedPriority 2In placeEvaluate the support console and record the trigger for the evaluation.HR leadSmall29 Dec 202618
10OR-01Every business associate and subcontractor that can reach ePHI is under a written agreementPriority 2In placeSign the ticketing tool's agreement, or stop using it for tickets that quote patient details.Vendor ownerSmall29 Dec 202619
11OR-03The register of business associates is completePriority 2In placeFill in the ticketing tool's review date.Vendor ownerSmall29 Dec 202621
12PH-03Devices and media are controlled, from receipt to disposalPriority 2In placeRecord each wipe and keep the certificate.Facilities leadSmall29 Dec 202625
13TE-01Every user has a unique identity and emergency access is definedPriority 2In placeRequire multi-factor sign-in for the support console; encrypt the 12 contractor laptops.Security officialSmall29 Dec 202626
14TE-03ePHI is protected from alteration and in transitPriority 2In placeRecord the encryption decision for exports and move exports to a secure download link.Security officialSmall29 Dec 202628
15BR-02Notification is ready to run on its clocksPriority 2In placeApprove the notice templates and test the contact list.Security officialSmall29 Dec 202632
16GV-03Leaders approve the risk analysis and oversee the planPriority 3In placeSet a reporting interval for the risk management plan and put it on the management review agenda.Security officialSmall29 Mar 20276
17BR-04The treatment of secured PHI is recordedPriority 3Not startedWrite down how the record of secured PHI is made, using HHS's guidance.Security officialSmall29 Mar 202734
18RS-01Recognised security practices have been in place for at least 12 months and can be shownPriority 3PlannedPut the practices in place, then keep the records for at least 12 months.Security officialSmall29 Mar 202735
19RS-02The proposed Security Rule changes are watchedPriority 3Not startedAssign a person to follow the proposed rule and report to the security official.Security officialSmall29 Mar 202736

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Order: Priority 1 first, then Priority 2, then Priority 3; within a priority, in the order of the Assessment sheet. The grey Row column is the item's position in the assessment table. To hand a gap over, copy it into the HIPAA Gap & Remediation Tracker (P31-A08), whose fields are: gap, readiness item, what is missing, priority, owner, effort, raised, due, status, done, evidence. The tracker sets each gap's due date: this date or an earlier one a plan already set.

Limitations

This is a self-assessment. It is as good as the evidence behind each level. A second person checking the levels of the blocking items is the best defence against optimism.

The result describes your records against these items. It is not a finding about the law, and it is not legal advice. The Rules provide no certificate of compliance, and no result here is one. Counsel confirms your role (P31-A02) and any Not applicable item.

A blocking item is one that rests on the Rule's text: a standard or a required specification of the Security Rule, or the breach notification rules. Recognised security practices (42 U.S.C. 17941) and the proposed Security Rule changes (90 FR 898) are not duties of the current Rule, and the items about them are never blocking.

A level of Operating on every item makes it likely, not certain, that your records would stand up if asked for. Whether each safeguard is reasonable and appropriate for you is a judgement the risk analysis supports, not this self-assessment.

Effort is an estimate in bands. Use it to plan and to ask for resources, not as a commitment.

The result is one of four words with the counts beside it. Never turn the counts into a percentage, a score or a traffic-light total.

Lists

LevelYesNoEffortAreaNamePriorityNamePriorityDaysNaItem
Not startedYesSmallRole and scopePriority 130SC-02
PlannedNoMediumGovernancePriority 290OR-04
In placeLargeRisk analysis and managementPriority 3180BR-03
OperatingWorkforce and operations
Not applicableBusiness associates

Physical safeguards

Technical safeguards

Documentation

Breach readiness

Beyond the minimum

Definitions

Definitions

TermMeaning in this workbook
Protected health information (PHI)Individually identifiable health information held or transmitted in any form or medium, with four exclusions (160.103).
Electronic protected health information (ePHI)PHI that is transmitted by electronic media or maintained in electronic media. It is what the Security Rule protects.
Covered entityA health plan, a health care clearinghouse, or a health care provider that transmits health information electronically in connection with a standard transaction.
Business associateA person who handles PHI for a covered entity (or for another business associate) in the way 160.103 describes, or provides listed services that involve disclosure of PHI to it. A subcontractor of a business associate that handles PHI for it is a business associate too.
Hybrid entityA single legal entity that is a covered entity, has both covered and non-covered functions, and has designated its health care components.
RequiredThe entity must implement it.
AddressableThe entity must assess whether it is a reasonable and appropriate safeguard in its environment, and then implement it, or document why not and implement an equivalent alternative measure if that is reasonable and appropriate. It is never optional and never skipped without a record.
Security officialThe one person identified as responsible for developing and implementing the security policies and procedures (164.308(a)(2)).
BreachAn acquisition, access, use or disclosure of PHI not permitted under the Privacy Rule that compromises its security or privacy (164.402), subject to three exclusions and the presumption the definition sets.
Unsecured PHIPHI that has not been rendered unusable, unreadable or indecipherable through a method HHS specifies in guidance, such as encryption with the key kept safe, or destruction.
ReadinessWhat your records show against an item of this pack today. It is not a finding that you comply with the law.
Standard and implementation specificationA standard is a requirement of the Security Rule. An implementation specification is a more detailed requirement under a standard, either required or addressable.
Blocking itemAn item marked Blocking: it rests on the Rule's own text. Below In place it is a blocking gap: Not started or Planned.
ResultOne of four words, with the counts beside it, set out on the Instructions sheet. Never a score.
Recognised security practicesSecurity practices an organisation chooses, such as a recognised framework. HITECH section 13412 asks the Secretary to consider whether they were in place for the previous 12 months. They are not a duty of the Security Rule.
HR-01 to HR-30The rules of this pack. HR-29 and HR-30 are quoted on the Instructions sheet.
EXAMPLEA worked example: Acme Corp (EXAMPLE), as at 2026-09-30. Clear the EXAMPLE column and the yellow answers before use.

Framework References

Framework references

These references indicate relevance only and do not reproduce the text of any standard.

FrameworkReferenceSupported by
ISO/IEC 27001:2022Clause 9.1 — Monitoring, measurement, analysis and evaluationThe workbook as a whole: a planned check of readiness, with its results recorded
NIST CSF 2.0GV.OV-03 — “Organizational cybersecurity risk management performance is evaluated and reviewed for adjustments needed”Results: the result and the gaps found, for the management body to oversee
HIPAA — 45 CFR Parts 160 and 164§ 164.306 — covered entities and business associates must ensure the confidentiality, integrity and availability of all electronic protected health information they create, receive, maintain or transmit, and protect against reasonably anticipated threats and impermissible uses and disclosures. They “may use any security measures that allow” them “to reasonably and appropriately implement the standards”, taking into account size, complexity and capabilities, technical infrastructure, “the costs of security measures” and “the probability and criticality of potential risks”. Each implementation specification is “required or addressable”. For an addressable one the entity must assess whether it is “a reasonable and appropriate safeguard in its environment” and then implement it if reasonable and appropriate or, if not, document why and “implement an equivalent alternative measure if reasonable and appropriate”. Security measures are reviewed and modified as needed (§ 164.306(e))DC-02 and the 'Operating when' texts: the general requirements, the factors that decide what is reasonable and appropriate, and the required or addressable treatment of each specification
HIPAA — 45 CFR Parts 160 and 164§ 164.308(a)(1) — the security management process standard: “Implement policies and procedures to prevent, detect, contain, and correct security violations.” Its four required implementation specifications are risk analysis (“an accurate and thorough assessment of the potential risks and vulnerabilities to the confidentiality, integrity, and availability of electronic protected health information”), risk management, a sanction policy and information system activity reviewRA-01 to RA-04 and GV-04: the risk analysis, risk management, sanction policy and information system activity review
HIPAA — 45 CFR Parts 160 and 164§ 164.308(a)(8) — 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”. The rule sets no intervalWS-07 and the reassessment rule HR-30: an evaluation, repeated when the environment or operations change
HIPAA — 45 CFR Parts 160 and 164§ 164.316 — policies and procedures in writing (which may be electronic) and a written record of any action, activity or assessment the subpart requires to be documented. Documentation is retained “for 6 years from the date of its creation or the date when it last was in effect, whichever is later”, made available to those who implement the procedures, and reviewed periodically and updated in response to environmental or operational changesDC-01: policies and procedures in writing, a written record of each assessment, retained and reviewed
HITECH Act, as codified in 42 U.S.C.42 U.S.C. 17941 (HITECH Act section 13412, added by Pub. L. 116-321, 5 January 2021) — when determining fines, the length and extent of an audit, or remedies, the Secretary “shall consider whether the covered entity or business associate has adequately demonstrated that it had, for not less than the previous 12 months, recognized security practices in place”. “Recognized security practices” are standards, guidelines, best practices, methodologies, procedures and processes developed under section 272(c)(15) of title 15 and section 1533(d) of title 6, and other cybersecurity programs developed, recognized or promulgated under other statutes; “Such practices shall be determined by the covered entity or business associate, consistent with the HIPAA Security rule”. The Secretary has no authority to increase fines for a lack of such practices, and an entity is not liable for electing not to engage in themRS-01: recognised security practices in place for the previous 12 months, an item that is never blocking
HHS proposed rule (not in force)“HIPAA Security Rule To Strengthen the Cybersecurity of Electronic Protected Health Information”, 90 FR 898 (6 January 2025). A notice of proposed rulemaking that would change 45 CFR Parts 160 and 164, chiefly the Security Rule (Subpart C). It is a proposal: comments closed on 7 March 2025 and no final rule was found in the Federal Register on 18 October 2026. The current text of the Security Rule is the text in Part 164 as the eCFR prints it. This pack is written to that text, and does not rely on the proposalRS-02: following a proposal, which this workbook does not apply and which is never blocking

Editions referenced: 45 CFR Parts 160 and 164 as the eCFR prints them (current to 6 October 2026); HITECH Act provisions at 42 U.S.C. 17931, 17934 and 17941; HHS Office for Civil Rights guidance on risk analysis, business associates and unsecured protected health information; NIST SP 800-66 Rev. 2 (informative); NIST CSF 2.0; ISO/IEC 27001:2022 incl. Amd 1:2024 (by number and title only); as published and read on 18 October 2026

ISO/IEC 27001 references name the clause or control this document relates to, by number and title only. No text of the standard is reproduced. A reference does not say that meeting a clause or control meets any requirement of the HIPAA Rules, or that your organisation holds a certificate.

The proposed rule published at 90 FR 898 is a proposal. It is not part of the text this pack applies. Counsel confirms its status before any document is relied on.

Prepared by Zero One Cybersecurity · Published by CISO Times

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