HDS compliance-matrix
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HIPAA Security Rule HIPAA-Security

regulation · US · 45 CFR Part 164 Subpart C (as amended through the HITECH 2013 Omnibus Final Rule) US · layered on Pryv hipaa-security

164.308(a)(1)(i) Security management process — standard draft

Implement policies and procedures to prevent, detect, contain, and correct security violations.

Pryv platform facilitated

The Security Management Process is a programme you run as the covered entity / business associate — risk analysis, risk-management decisions, sanctions, activity review. Pryv supplies the technical raw material (audit log, system-level observability) that several of those activities draw on — particularly the §164.308(a)(1)(ii)(D) Information System Activity Review specification. The umbrella programme itself remains yours to define and run.

HDS documented USCH

As an operator HDS runs its own security-management programme over the open-pryv.io platform, covering the four required specifications below (risk analysis, risk management, sanction policy, activity review). The umbrella programme is documented internally and made available on request; a partner running their own ePHI workload still maintains their own.

detail

HDS inherits the platform substrate (per-user audit log, system-level observability) that several specifications draw on, and wraps it in a written, maintained programme that is reviewed periodically. The four child specifications each carry their own row where the contribution is more concrete. For a partner acting as Covered Entity or upstream BA, this is a programme they must run themselves; HDS supplies the technical raw material and its own programme as evidence of operator diligence.

  • 🔒 hipaa/policies/security-management-process available on request
Implementer
covered-entity documented

Define, document and maintain your own security-management programme; you may reference HDS's technical safeguards as inputs.

business-associate documented

Run your own security-management programme covering the ePHI you process, citing HDS substrate where it carries part of the control.

individual out-of-scope

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

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

Pryv platform implemented

Every API call is captured by Pryv's per-user audit log; the `audit.get` method exposes it for periodic review. Observability (New Relic adapter) gives system-level activity reports for the infrastructure side. The "regular review" cadence is your written procedure.

HDS implemented USCH

On top of the platform's per-user audit log, HDS operates the review substrate: system-level activity is collected and monitored across both US and Switzerland data-residency options, with alerting on crash, error-rate and silence conditions. The written review cadence remains the implementer's responsibility.

detail

Per-API-call audit records (platform layer) plus infrastructure telemetry (HDS layer) together give both subject-level and system-level activity review. HDS operates the alerting chain end to end as a matter of policy before any component is treated as in production, so silent failures are caught. The documented review procedure HDS runs as operator is available on request.

  • 🔒 hipaa/procedures/information-system-activity-review available on request
Implementer
covered-entity documented

Define and document your review cadence and who performs it, and retain the review records per your retention policy.

business-associate documented

Establish your own periodic review of activity records for the ePHI you process, drawing on the audit and monitoring substrate HDS exposes.

individual out-of-scope

164.308(a)(2) Assigned security responsibility — standard draft

Identify the security official who is responsible for developing and implementing the policies and procedures required by this subpart.

Pryv platform out-of-scope

Security-official designation is HR / organizational. No software role. When the assigned official needs operational data, the audit log + observability + this matrix are the substrate they draw on.

HDS documented USCH

HDS designates a named security official accountable for its security programme over the platform; the designation is recorded internally and disclosed on request. Each partner must designate their own official for their own programme.

detail

This is an organisational designation, not a software control. HDS holds the designation as an operator artefact; the assigned official draws on the audit log, monitoring and this matrix as operational substrate. A partner running ePHI on HDS names their own security official.

  • 🔒 hipaa/policies/assigned-security-responsibility available on request
Implementer
covered-entity documented

Designate and document your own security official.

business-associate documented

Designate and document your own security official.

individual out-of-scope

164.308(a)(3)(ii)(C) Termination procedures — Addressable draft

Implement procedures for terminating access to ePHI when employment ends or a workforce member's role changes.

Pryv platform implemented

Workforce access to ePHI is mediated by Pryv accesses. Termination is a single API call (`accesses.delete`) which immediately revokes the token. The audit log proves the termination instant. For role-change scenarios, `accesses.update` narrows permissions without full revocation, preserving the version history of the change.

HDS implemented USCH

Workforce access to ePHI is mediated by platform access tokens with granular per-stream permissions. Termination is a single revocation that takes effect immediately, and the audit log records the termination instant; role changes narrow permissions without losing the version history of the change.

detail

HDS operates the access-token model so that ending or changing a workforce member's access is an immediate, audited operation rather than a manual clean-up across systems. Full revocation removes the token; narrowing reduces permissions while preserving the access identity and its history. HDS documents the termination procedure it follows for its own workforce; partners apply the same primitives to their own staff.

  • 🔒 hipaa/procedures/access-termination available on request
Implementer
covered-entity documented

Document your termination workflow and tie it to revocation of the access tokens your workforce holds.

business-associate documented

Document your termination workflow for staff who handle the ePHI you process on HDS.

individual out-of-scope

164.308(a)(4)(ii)(B) Access authorization — Addressable draft

Implement policies and procedures for granting access to ePHI through a workstation, transaction, program, process, or other mechanism.

Pryv platform implemented

Granting access to ePHI in Pryv means minting an access with explicit per-stream permissions. The technical authorization decision is enforced at every API call. Documentation of the authorization rationale lives in `access.clientData` next to the grant itself, so the "why" travels with the "what".

HDS implemented USCH

Granting access to ePHI on HDS means minting an access token with explicit per-stream permissions, enforced at every API call. The authorization rationale can travel alongside the grant itself, so the "why" stays with the "what".

detail

Access grants carry the streams and levels the grantee may exercise, plus free-form metadata such as workforce role, granting administrator and business reason. HDS operates this as the authoritative authorization mechanism for ePHI; there is no trust-based bypass path. HDS documents its own authorization policy and partners apply the same primitive.

  • 🔒 hipaa/policies/access-authorization available on request
Implementer
covered-entity documented

Document who may authorise access and on what basis, and capture the rationale alongside each grant.

business-associate documented

Document your authorization policy for access to the ePHI you process.

individual out-of-scope

164.308(a)(4)(ii)(C) Access establishment and modification — Addressable draft

Implement policies and procedures to establish, document, review, and modify a user's right of access, based on the entity's access authorization policies.

Pryv platform implemented

The access lifecycle (create / read / update / delete) is first- class in Pryv. `accesses.update` writes a tamper-evident snapshot of the prior version into history on every modification, giving you the documented review trail this standard expects.

HDS implemented USCH

The access lifecycle (create, read, review, update, revoke) is first-class on the platform HDS operates. Every modification snapshots the prior version into history and is recorded in the audit log, giving the documented review trail this specification expects.

detail

HDS operates establishment, review and modification of access rights as audited operations: grants can be enumerated with their full version chain, narrowed or revoked, with each step timestamped and attributed to the acting administrator. HDS documents its own establishment-and-review cadence; partners apply the same primitives.

  • 🔒 hipaa/procedures/access-review available on request
Implementer
covered-entity documented

Document your establishment-and-modification workflow and your periodic access-review cadence.

business-associate documented

Document how you establish, review and modify access to the ePHI you process on HDS.

individual out-of-scope

164.308(a)(5)(ii)(A) Security reminders — Addressable draft

Implement periodic security updates and reminders for the workforce.

Pryv platform out-of-scope

Reminder cadence + content are organizational. Pryv has no role at the awareness-content layer.

HDS facilitated USCH

Security-reminder cadence and content are an organisational awareness control with no software role. HDS runs reminders for its own workforce and documents the programme; the artefact is available on request but training delivery itself is not yet formalised as a verified programme.

detail

HDS treats security reminders as part of its workforce-awareness programme, an operator artefact rather than a platform feature. The written programme is cited as an internal document. Formal, verified security-awareness training is a known gap being matured; each partner runs its own reminder programme for its own workforce.

  • 🔒 hipaa/policies/security-awareness-reminders available on request
Implementer
covered-entity documented

Run and document your own periodic security reminders for your workforce.

business-associate documented

Run and document your own security reminders for staff handling ePHI.

individual out-of-scope

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

Implement procedures for guarding against, detecting, and reporting malicious software.

Pryv platform out-of-scope

Anti-malware is a host / endpoint / network-layer control — Pryv-the-software doesn't include AV. Same out-of-scope reasoning as ISO 27001 A.8.7. The operator's hosting environment carries this control.

HDS facilitated USCH

Anti-malware is a host, endpoint and network-layer control rather than a platform feature. HDS operates malware protection and patching at the hosting layer for the environments it runs, documented internally; the partner's own endpoints remain the partner's responsibility.

detail

HDS's hosting environment carries malware-protection controls as part of operator-side infrastructure hardening, described privately and cited as an internal document. The platform software itself includes no antivirus. Partners must protect their own workstations and any infrastructure they operate outside HDS.

  • 🔒 hipaa/policies/malware-protection available on request
Implementer
covered-entity documented

Operate and document anti-malware controls on your own endpoints and infrastructure.

business-associate documented

Operate and document anti-malware controls on infrastructure you run outside HDS.

individual out-of-scope

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

Implement procedures for monitoring log-in attempts and reporting discrepancies.

Pryv platform facilitated

Login + authentication- failure events are captured in the audit log (per `auth.*` API method calls). Observability data aggregates rate + anomaly signals. The discrepancy-reporting cadence + threshold tuning are operator-side procedure.

HDS facilitated USCH

Authentication and login-failure events are captured in the per-user audit log, and HDS's operational monitoring aggregates rate and anomaly signals across both data-residency options. Discrepancy-reporting thresholds and the response cadence are operator-side procedure.

detail

HDS surfaces login and authentication-failure events through the audit log and layers monitoring on top to detect anomalous rates. The platform does not by itself lock accounts after N failures; HDS operates additional rate-limiting and alerting at the infrastructure boundary, documented privately. Partners tune their own discrepancy thresholds.

  • 🔒 hipaa/procedures/login-monitoring available on request
Implementer
covered-entity documented

Define and document your discrepancy thresholds and the response when a threshold is crossed.

business-associate documented

Define and document login-monitoring thresholds for the ePHI workload you operate.

individual out-of-scope

164.308(a)(5)(ii)(D) Password management — Addressable draft

Implement procedures for creating, changing, and safeguarding passwords.

Pryv platform configurable

Pryv stores credentials on a privileged `system-stream`, separate from ordinary content. Password rules (complexity, rotation) are operator-configured. Adding `services.mfa.mode` raises the authentication strength beyond a password alone — see §164.312(d).

HDS implemented USCH

The platform stores credentials on a privileged, separately controlled namespace, and HDS configures password rules and offers a second authentication factor on top. HDS operates and documents the resulting password-management posture.

detail

Credentials live apart from ordinary content data; password complexity and rotation rules are operator-configured and multi-factor authentication strengthens the login beyond a password alone (see the person-or-entity-authentication standard). HDS documents the configuration it runs; partners may layer their own additional rules.

  • 🔒 hipaa/procedures/password-management available on request
Implementer
covered-entity documented

Document your password policy and whether you require the second factor for your workforce.

business-associate documented

Document password-management procedures for staff handling ePHI.

individual out-of-scope

164.308(a)(6)(i) Security incident procedures — standard draft

Implement policies and procedures to address security incidents.

Pryv platform facilitated

Incident-response procedure is the operator's organizational programme. Pryv contributes the detection + scoping data layer: audit log shows who accessed what; observability gives system-level anomaly signals; access primitives provide the containment mechanism (revoke or scope-down the implicated access). For substrate-vulnerability intake specifically (operator learning that the Pryv version they run has a confirmed vulnerability), the upstream's vulnerability disclosure program is the externally-facing channel — today minimal (SECURITY.md is a 6-line pointer at the public issue tracker); modernised by backlog `VULNERABILITY-DISCLOSURE-PROGRAM` (private GHSA flow + `security@` mailbox + PGP + advisory history).

HDS documented USCH

HDS runs an incident-response programme as operator: the audit log and operational monitoring provide detection and scoping data, and access tokens provide the containment mechanism (revoke or narrow the implicated access). The written incident procedure is held internally and shared on request.

detail

Detection draws on per-user audit records (who accessed what) and system-level anomaly signals; containment uses immediate token revocation or scope reduction. HDS documents its incident-handling and notification flow, which feeds the breach-reporting obligations a partner carries under their BAA. Partners run their own incident programme for their workload.

  • 🔒 hipaa/procedures/security-incident-response available on request
Implementer
covered-entity documented

Run and document your own incident-response procedures.

business-associate documented 📄 baa

Run and document your own incident procedures and report incidents to the covered entity per your BAA.

individual out-of-scope

164.308(a)(7)(ii)(A) Data backup plan — Required draft

Establish and implement procedures to create and maintain retrievable exact copies of ePHI.

Pryv platform implemented

`bin/backup.js` produces per-user backup files (events, streams, accesses, attachments). `--restore` rebuilds a user from a backup file. The backup procedure ("when, where, how often") is yours to schedule; the underlying primitive is shipped.

HDS facilitated USCH

The platform produces per-user backup files (events, streams, accesses, attachments) with a matching restore path, so the backup unit matches the natural ePHI unit. HDS operates a backup schedule on top; automated, regularly verified backups are still being formalised, so this is facilitated rather than fully implemented.

detail

HDS runs the backup primitive on a schedule and documents the plan (frequency, location, encryption-at-rest applied at the storage boundary). Verified, automatically tested backups are a known gap being matured; the backup plan as it stands is cited as an internal document. Partners operating their own deployments define their own schedule.

  • 🔒 hipaa/procedures/data-backup-plan available on request
Implementer
covered-entity documented

Document your backup schedule, storage location and retention, and confirm restorability.

business-associate documented

Document the backup plan for the ePHI you process on HDS.

individual out-of-scope

164.308(a)(7)(ii)(B) Disaster recovery plan — Required draft

Establish, and implement as needed, procedures to restore any loss of data.

Pryv platform configurable

Two layers Pryv gives you: (1) cold restore from `bin/backup.js --restore`, the canonical recovery path; (2) hot redundancy via a multi-core cluster (rqlite replication + cluster-CA mTLS between cores), so a single-region failure doesn't lose live data. You compose them per your RTO / RPO.

HDS documented USCH

HDS combines cold restore from per-user backups with hot redundancy from a replicated multi-core platform topology, composed to a recovery objective HDS documents internally. The written disaster-recovery plan is available on request.

detail

Recovery rests on two layers: restore from backup as the canonical path, and live replication across cores so a single-region failure does not lose live data. HDS documents the recovery objectives and runbook it operates; contingency-plan testing is tracked separately (see the testing-and- revision specification, a known gap). Partners running their own deployments document their own plan.

  • 🔒 hipaa/procedures/disaster-recovery-plan available on request
Implementer
covered-entity documented

Document your recovery objectives and the steps to restore data after a loss event.

business-associate documented

Document the disaster-recovery procedures for your ePHI workload.

individual out-of-scope

164.308(a)(7)(ii)(C) Emergency mode operation plan — Required draft

Establish, and implement as needed, procedures to enable continuation of critical business processes for protection of ePHI while operating in emergency mode.

Pryv platform facilitated

Pryv's HA primitives (multi-core cluster + Raft replication + cluster-CA mTLS) support continued operation when a single facility fails. The "critical business processes" definition + emergency-mode runbook are the operator's. See also Art.5+ of the Disaster Recovery row.

HDS documented USCH

The platform's high-availability primitives (replicated multi-core cluster with mutually authenticated inter-core traffic) support continued operation when a single facility fails. HDS documents which processes are critical and the emergency-mode runbook it operates.

detail

HDS treats emergency-mode operation as a documented runbook layered on the platform's HA topology and backup-restore path. The definition of critical business processes and the emergency procedures are operator artefacts, cited internally. Partners define their own emergency-mode plan for their workload.

  • 🔒 hipaa/procedures/emergency-mode-operation available on request
Implementer
covered-entity documented

Define your critical processes and document the emergency-mode runbook.

business-associate documented

Document emergency-mode procedures for the ePHI you process.

individual out-of-scope

164.308(a)(7)(ii)(D) Testing and revision procedures — Addressable draft

Implement procedures for periodic testing and revision of contingency plans.

Pryv platform out-of-scope

Contingency-plan testing is an operational drill. Pryv has no software role at the drill-execution layer. The drill's restoration-from-backup phase exercises Pryv primitives but the testing programme itself is the operator's.

HDS documented USCH

Contingency-plan testing is an operational drill whose restore phase exercises the platform's backup-restore path. HDS is formalising a regular test-and-revise cadence; the procedure is documented internally and regular verified execution remains a known gap.

detail

The testing programme itself is an operator activity rather than a platform feature, though restore drills run against the platform's backup primitive. HDS documents the intended cadence and revision process and is maturing verified, scheduled execution. Partners run and document their own contingency-plan tests.

  • 🔒 hipaa/procedures/contingency-plan-testing available on request
Implementer
covered-entity documented

Schedule, run and document periodic tests of your contingency plans and revise them based on results.

business-associate documented

Test and revise your contingency plans periodically and keep the records.

individual out-of-scope

164.308(a)(8) Evaluation — standard draft

Perform periodic technical and nontechnical evaluation, in response to environmental or operational changes, to confirm that security policies and procedures continue to meet the requirements of this subpart.

Pryv platform facilitated

Evaluation is the operator's cyclical assessment. Pryv-side inputs: audit log (control- effectiveness sample), observability (operational stability data), this matrix (control inventory to evaluate against), Pryv's test matrix (~2351 PG and SQLite, matched baseline, passing on every commit — concrete §164.308(a)(8) effectiveness evidence), Pryv's supply-chain pipeline (Q24 backlog `SUPPLY-CHAIN- SCANNING-PIPELINE` once shipped), Pryv's vulnerability disclosure program + GHSA advisory history (backlog `VULNERABILITY-DISCLOSURE-PROGRAM` once shipped). The assessment write-up is operator-side.

HDS documented USCH

HDS performs a periodic evaluation of its security programme, drawing on the audit log, operational monitoring, this matrix as a control inventory, and the platform's test results as control-effectiveness evidence. The evaluation write-up is held internally and shared on request.

detail

Inputs to the evaluation include audit-log samples, operational-stability data, this layered matrix as the inventory of controls to assess against, and the platform's automated test suite as ongoing effectiveness evidence. HDS documents the cadence and findings; a partner runs its own periodic evaluation for its own programme.

  • 🔒 hipaa/procedures/periodic-evaluation available on request
Implementer
covered-entity documented

Perform and document your own periodic technical and nontechnical evaluation.

business-associate documented

Perform and document a periodic evaluation of the safeguards over the ePHI you process.

individual out-of-scope

164.310 Physical Safeguards — standard (framing) draft

Implement policies and procedures to limit physical access to electronic information systems and the facilities in which they are housed, while ensuring that properly authorized access is allowed.

Pryv platform facilitated

Physical safeguards (facility access, workstation security, device and media controls) are properties of the hosting environment, not of the Pryv software itself. Pryv contributes two things: the data-residency primitive lets you bind a user's data to a specific hosting (so you can certify the physical environment for that data explicitly), and operator-supplied secrets are AES-256-GCM encrypted at rest so that a stolen disk doesn't leak the keys themselves.

HDS facilitated USCH

Physical safeguards are properties of the hosting environment, not of the open-pryv.io software. HDS carries this layer by selecting certified hosting providers (EU/Switzerland and US data-residency options) and documenting the facility-control attestations it relies on, so an implementer inherits a vetted physical posture rather than sourcing it themselves.

detail

For each specification under §164.310 (facility access controls, workstation use, workstation security, device and media controls), the underlying controls are physical and operational. HDS's position: HDS chooses and documents the hosting environment per region, binds a deployment to that region's data residency, and holds the provider attestations on file. The facility-control hardware itself remains the certified provider's; HDS's contribution is selection, documentation and the residency guarantee.

  • 🔒 hipaa/policies/physical-safeguards available on request
  • 🔒 hipaa/registers/hosting-provider-attestations available on request
Implementer
covered-entity documented

Rely on the HDS-selected hosting region for the server-side facility controls; you remain responsible for the physical security of your own offices, endpoints and any workforce devices that access ePHI.

business-associate documented

Inherit the HDS hosting-region facility posture and document it in your own physical-safeguards programme; cover your own premises and devices.

individual out-of-scope

164.310(a)(1) Facility access controls — standard draft

Implement policies and procedures to limit physical access to electronic information systems and the facilities housing them, while ensuring properly authorized access is allowed.

Pryv platform out-of-scope

Facility access is physical. See the §164.310 framing row.

HDS facilitated USCH

Facility access control at the server tier is delivered by the certified hosting provider for the chosen region. HDS selects providers whose data-centre access controls (badged entry, escort policies, access logging) are independently attested, and documents which attestation backs each region.

detail

HDS does not operate its own data centres; it deploys open-pryv.io onto certified infrastructure in the EU/Switzerland and US regions. The facility-access-control specification is satisfied at the server tier by the provider's attested controls, which HDS records in its hosting-provider register. The implementer's own facilities (offices where workforce members access ePHI) remain their responsibility.

  • 🔒 hipaa/registers/hosting-provider-attestations available on request
  • 🔒 hipaa/policies/physical-safeguards available on request
Implementer
covered-entity documented

Inherit the server-tier facility controls from the HDS hosting region; implement and document facility access controls for your own premises.

business-associate documented

Same as covered entity — server tier inherited, your own facilities are yours to control and document.

individual out-of-scope

164.310(b) Workstation use — standard draft

Implement policies and procedures specifying the proper functions to be performed, how they are to be performed, and the physical attributes of the surroundings of any workstation or class of workstation that can access ePHI.

Pryv platform out-of-scope

Workstation use + physical attributes are facility / HR controls.

HDS documented USCH

Workstation use is a workforce and endpoint-management control that sits with the entity operating the workstations, not with the HDS platform. HDS documents the assumption that ePHI access happens only through authenticated, access-token-scoped sessions, which bounds what any single workstation can do.

detail

open-pryv.io enforces that every workstation reaching ePHI does so through an authenticated session carrying a scoped access token, so a workstation can only exercise the permissions its token grants. The physical-surroundings and proper-function obligations of the workstation-use standard remain organizational. HDS records this boundary so implementers can scope their own workstation-use policy to the residual physical/operational concerns.

  • 🔒 hipaa/policies/physical-safeguards available on request
Implementer
covered-entity documented

Define and document workstation-use rules for the devices your workforce uses to access ePHI through the HDS-hosted application.

business-associate documented

Same — your workforce workstation-use policy is yours to author.

individual out-of-scope

164.310(c) Workstation security — standard draft

Implement physical safeguards for all workstations that access ePHI, to restrict access to authorized users.

Pryv platform out-of-scope

Physical workstation security (screen locks, kensington locks, privacy filters) is endpoint-management scope.

HDS documented USCH

Physical workstation security (screen locks, device controls, premises) is endpoint-management scope owned by the entity operating the workstation. HDS documents the compensating platform control: a lost or unattended workstation cannot exceed the permissions of its access token, and the token can be revoked centrally.

detail

The physical safeguards the standard calls for — restricting who can be at a workstation that reaches ePHI — are facility and endpoint controls outside the HDS platform. HDS's compensating contribution is that workforce access is mediated by revocable, per-stream access tokens with session/token expiry, so the blast radius of a compromised workstation is bounded and recoverable. HDS documents this so implementers can right-size their physical workstation controls.

  • 🔒 hipaa/policies/physical-safeguards available on request
Implementer
covered-entity documented

Implement physical workstation safeguards (screen locks, restricted siting, device management) for endpoints accessing ePHI; revoke HDS access tokens on device loss.

business-associate documented

Same physical-workstation obligations apply to your own endpoints.

individual out-of-scope

164.310(d)(1) Device and media controls — standard draft

Implement policies and procedures governing the receipt and removal of hardware and electronic media containing ePHI into and out of a facility, and the movement of these items within the facility.

Pryv platform facilitated

Pryv-side contribution at the media-controls layer: per-user backup files are the natural unit when an individual subject's ePHI moves off the production system (export, transfer, archive); operator-side at-rest encryption (LUKS / PG TDE) keeps the ePHI-on-media encrypted in motion + at rest. The physical movement procedure is the operator's.

HDS facilitated USCH

Media disposal and re-use at the server tier are handled by the certified hosting provider's media-sanitisation controls, which HDS selects and documents. For per-subject ePHI movement, the platform's per-user export unit is the natural medium so a single subject's data can be transferred or archived discretely.

detail

The server-tier device-and-media-controls obligation (secure disposal, media re-use, sanitisation) is satisfied by the hosting provider's attested controls, recorded in the HDS hosting-provider register. At the application tier, open-pryv.io's per-user data model means an individual subject's ePHI can be exported and moved as a discrete unit. Note: platform at-rest encryption of bulk event data is not yet shipped, so media leaving the production environment must be encrypted by the implementer's own at-rest layer before transport — HDS documents this boundary explicitly.

  • 🔒 hipaa/registers/hosting-provider-attestations available on request
  • 🔒 hipaa/procedures/media-controls available on request
Implementer
covered-entity documented

Inherit server-tier media sanitisation from the hosting provider; apply your own at-rest encryption to any per-subject export you move off the platform, and document the movement.

business-associate documented

Same — server-tier inherited, your own media-handling and at-rest encryption of exports is your responsibility.

individual out-of-scope

164.312(a)(1) Access control — standard draft

Implement technical policies and procedures for electronic information systems holding ePHI so that access is allowed only to persons or software programs granted access rights under §164.308(a)(4).

Pryv platform implemented

Per-stream permissions are enforced at every API call; an access can read or write only the streams its `permissions[]` lists, at the level granted. There is no "bypass on trust" path — the enforcement is the API surface, not a downstream policy layer. System streams (account, password, MFA) sit on a separately controlled namespace.

HDS implemented USCH

HDS deploys open-pryv.io with per-user data isolation and per-stream access tokens enforced at every API call: a token can read or write only the streams its permissions list, at the level granted, with no trust-based bypass path. Access control is therefore a technical property of the API surface that HDS operates, not a downstream policy layer.

detail

Each subject's data is isolated per user, and access by any person or program is mediated by an access token carrying explicit per-stream, per-level permissions. Enforcement happens at the API boundary on every request, and privileged namespaces (account, credentials) are separately controlled. HDS operates this stack and documents its access-control policy; the implementer configures which grants their application mints.

  • 🔒 hipaa/policies/access-control available on request
Implementer
covered-entity documented

Configure your application's use of HDS access tokens to grant least- privilege per-stream access, and document your access-authorization rules.

business-associate documented

Same — model your grants as least-privilege per-stream access tokens and document the authorization scheme.

individual out-of-scope

164.312(a)(2)(i) Unique user identification — Required draft

Assign a unique name and/or number for identifying and tracking user identity.

Pryv platform implemented

Every Pryv account has a unique username + cuid; every access derived from it carries a unique access id (cuid) and version serial. Audit records cite the (accessId, accessSerial) tuple, so each tracked action ties back to a unique identity.

HDS implemented USCH

Every account in the HDS-operated platform has a unique identifier, and every access token derived from it carries a unique id and version. The per-user audit log cites that access identity on every recorded action, so each tracked operation ties back to a unique identity.

detail

Unique identification is intrinsic to the platform: accounts and the access tokens minted from them each carry unique identifiers, and the audit record for every API call references the acting access identity. This gives the requirement's "identify and track" obligation a technical anchor that HDS operates by default. The implementer maps their workforce/role model onto these identities.

  • 🔒 hipaa/policies/access-control available on request
Implementer
covered-entity documented

Map each workforce member or program to a distinct identity/access token and document the mapping; avoid shared credentials.

business-associate documented

Same — one identity per actor, documented.

individual out-of-scope

164.312(a)(2)(ii) Emergency access procedure — Required draft

Establish (and implement as needed) procedures for obtaining necessary ePHI during an emergency.

Pryv platform configurable

The operator-held admin access key (`auth.adminAccessKey`) is the break-glass mechanism: it grants administrative reads not requiring an ordinary user's consent. You document the circumstances under which it may be exercised and the audit-trail review that must follow.

HDS configurable USCH

The platform provides an operator-held administrative access mechanism that can serve as a break-glass path to ePHI during an emergency, and every action taken under it is captured by the per-user audit log. HDS documents the custody controls; the implementer defines when the procedure may be invoked and the review that follows.

detail

Emergency access is supported by an operator-held privileged access capability treated as a custody-controlled credential. Because every call made under it is audited like any other, post-emergency review is concrete and the break-glass event is reconstructable. HDS configures and safeguards the mechanism; the implementer authors the emergency-access procedure (triggers, authorisers, mandatory after-action review) on top of it.

  • 🔒 hipaa/procedures/emergency-access available on request
Implementer
covered-entity configurable

Define and document your emergency-access procedure — who may invoke break-glass access, under what conditions, and the mandatory audit review afterward.

business-associate configurable

Same — author and document your own emergency-access procedure over the platform mechanism.

individual out-of-scope

164.312(a)(2)(iii) Automatic logoff — Addressable draft

Implement electronic procedures that terminate an electronic session after a predetermined time of inactivity.

Pryv platform configurable

Two configurables: personal-token session lifetime (`auth.sessionMaxAge`) and per-access expiry (`access.expires`). The latter is per-grant (the access is automatically inert after the timestamp passes) — useful for clinical-workflow accesses whose validity is bounded by the case.

HDS configurable USCH

The platform enforces automatic session and token expiry: interactive session lifetime and per-grant access-token expiry can both be bounded, so a session or token becomes inert automatically once its window passes. HDS operates the mechanism; the implementer sets the timeouts appropriate to its workflow.

detail

HIPAA's automatic-logoff specification is workstation-centric in origin; in an HDS-mediated workflow the analogous control is the validity window of the session and access token. The platform supports a bounded interactive session lifetime for workforce sessions and a per-grant token expiry for app-driven processes, covering both shapes. HDS documents the configured defaults; the implementer tunes them and documents the rationale for the chosen inactivity window (the "Addressable" path).

  • 🔒 hipaa/policies/access-control available on request
Implementer
covered-entity configurable

Set session and access-token expiry windows appropriate to your workflow and document the inactivity-timeout decision.

business-associate configurable

Same — configure and document timeout windows for your application's sessions and tokens.

individual out-of-scope

164.312(a)(2)(iv) Encryption and decryption — Addressable draft

Implement a mechanism to encrypt and decrypt ePHI.

Pryv platform configurable

Pryv encrypts operator-supplied secrets at rest using AES-256-GCM (HKDF-derived per-key), and provides TLS-in-transit via the built-in ACME integration. For ePHI itself, the operator chooses the storage engine and its at-rest encryption posture (filesystem encryption, PG TDE, etc.) — Pryv does not encrypt event content with a Pryv-managed key.

HDS facilitated USCH

TLS protects ePHI in transit by default, but platform-managed at-rest encryption of bulk event data is not yet shipped. HDS therefore facilitates this requirement at the infrastructure layer — applying provider-side at-rest encryption (volume/storage encryption) in the chosen hosting region — and documents the gap honestly rather than claiming it as implemented.

detail

This is a known gap and is stated plainly: the platform does not yet encrypt event content with a platform-managed key. HDS covers at-rest protection at the infrastructure layer using the hosting provider's storage/volume encryption in each region, and TLS covers the transmission half (see §164.312(e)). HDS documents the at-rest posture and the boundary it does not yet cover so implementers can assess residual risk and apply additional at-rest controls where their risk analysis requires.

  • 🔒 hipaa/policies/encryption available on request
  • 🔒 hipaa/risk/at-rest-encryption-gap available on request
Implementer
covered-entity configurable

Assess the at-rest encryption gap in your own risk analysis; apply additional at-rest controls (e.g. application-side encryption of sensitive fields) where warranted, and document the addressable decision.

business-associate configurable

Same — evaluate and, where needed, supplement at-rest encryption, and document the decision.

individual out-of-scope

164.312(b) Audit controls — standard draft

Implement hardware, software, and/or procedural mechanisms that record and examine activity in information systems containing or using ePHI.

Pryv platform implemented

Pryv's per-user audit log records every API method invocation — timestamp, user, access reference, method, success / error. The `audit.get` API method surfaces it for examination. The optional audit-event-stream channel additionally emits audit records into the subject's own streams, so the subject (and any access they authorise) can examine the history.

HDS implemented USCH

The HDS-operated platform records every API call in a per-user audit log — timestamp, acting access identity, method, and success/error — and exposes it for examination. The audit record is data-minimal by construction (request bodies are not stored), so reviewing activity does not create a second copy of ePHI.

detail

Audit controls are a native, always-on property of the platform: each API invocation against a subject's data produces an audit record scoped to that subject. The log captures who did what, when, and via which access, and is retrievable for routine review and incident investigation. HDS operates and retains this substrate; the implementer defines the written review cadence (see §164.308(a)(1)(ii)(D)) and who performs it.

  • 🔒 hipaa/policies/audit-controls available on request
  • 🔒 hipaa/procedures/information-system-activity-review available on request
Implementer
covered-entity documented

Define and document your audit-review cadence and who performs it; retain the review records per your retention policy.

business-associate documented

Same — own the written review procedure over the platform-provided log.

individual out-of-scope

164.312(c)(1) Integrity — standard draft

Implement policies and procedures to protect ePHI from improper alteration or destruction.

Pryv platform facilitated

Integrity is multi- layered: write authorization gated by `permissions`, event versioning preserves the prior value on every update, audit pins the (who, when, via which access) attribution, and `bin/backup.js` provides the recovery path if a destruction event needs to be reversed. The standard's overall programmatic obligation is yours; the technical substrate is Pryv's.

HDS facilitated USCH

Integrity is layered in the HDS-operated platform: writes are gated by per-stream permissions, updates preserve the prior value through versioning, the audit log pins who-changed-what-when, and operational backups provide a recovery path if a destruction event must be reversed. The overall integrity programme remains the implementer's; the technical substrate is HDS-operated.

detail

Improper alteration is constrained because only tokens with write permission on a stream can modify it, and modifications are versioned so the prior state is retained. Improper destruction is mitigated by per-user export/backup as a recovery path. The audit log ties every change to an authenticated access identity. HDS operates these primitives and documents its integrity policy; the implementer owns the surrounding procedural obligation.

  • 🔒 hipaa/policies/integrity available on request
Implementer
covered-entity documented

Author your integrity policy — change-control, who may alter records, and how destruction is prevented and recovered — over the platform substrate.

business-associate documented

Same — document your integrity-protection procedures.

individual out-of-scope

164.312(c)(2) Mechanism to authenticate ePHI — Addressable draft

Implement electronic mechanisms to corroborate that ePHI has not been altered or destroyed in an unauthorized manner.

Pryv platform facilitated

Event versioning preserves the prior content on every update, so "is this the original?" is a tractable question — compare against the history. The audit row references the access that performed the update, anchoring the change to an authenticated actor. Tamper detection beyond this (e.g., end-to-end content hashing under a customer-held key) is on the implementer or an extension.

HDS facilitated USCH

Event versioning retains prior content on every update, so "is this the original?" is answerable by comparison against the history, and the audit record anchors each change to an authenticated access identity. Tamper detection beyond this — e.g. cryptographic content hashing under an implementer-held key — remains on the implementer or an extension.

detail

The platform corroborates that ePHI has not been altered improperly through two evidence sources HDS operates: the version history of each record, and the audit attribution of every change to an authenticated actor. This satisfies the addressable specification's evidentiary intent for most deployments. HDS documents the boundary; where an implementer's risk analysis demands stronger tamper-proofing, they layer in content-integrity verification themselves.

  • 🔒 hipaa/policies/integrity available on request
Implementer
covered-entity configurable

Decide, per your risk analysis, whether the platform's versioning + audit evidence suffices or whether to add content-integrity verification, and document the addressable decision.

business-associate configurable

Same — assess and document the integrity-corroboration approach.

individual out-of-scope

164.312(d) Person or entity authentication — standard draft

Implement procedures to verify that a person or entity seeking access to ePHI is the one claimed.

Pryv platform implemented

Authentication is mediated by the access-token primitive: the bearer of a valid token has been authenticated. Strength of that authentication is layered — username + password by default; MFA via `mfa.*` API methods when `services.mfa.mode` is set. Recovery paths preserve account ownership when a second-factor device is lost.

HDS implemented USCH

Authentication in the HDS-operated platform is mediated by the access-token primitive: the bearer of a valid token has been authenticated. Authentication strength is layered — credentials by default, with multi-factor authentication available — and recovery paths preserve account ownership when a factor is lost.

detail

Every request reaching ePHI must present a valid access token, so the platform verifies the requester before any access is granted. HDS operates this stack and can require multi-factor authentication where the implementer's risk profile calls for it; the achievable assurance level depends on which factor method is configured. HDS documents the authentication policy in effect; the implementer decides whether to require MFA universally or per-role.

  • 🔒 hipaa/policies/authentication available on request
Implementer
covered-entity documented

Decide and document your authentication strength (e.g. whether MFA is required, and for which roles or operations).

business-associate documented

Same — set and document your authentication policy over the platform.

individual out-of-scope

164.312(e)(1) Transmission security — standard draft

Implement technical security measures to guard against unauthorized access to ePHI being transmitted over an electronic communications network.

Pryv platform implemented

All Pryv API traffic terminates on TLS 1.3 by default, with certificates issued + auto-renewed via the built-in ACME integration. Inter-core traffic in a multi-core cluster runs over mTLS using a cluster-private CA. There is no plaintext path shipped.

HDS implemented USCH

All API traffic to the HDS-operated platform is carried over TLS by default; there is no plaintext path served. Transmission security is therefore a technical property of every connection rather than an optional add-on, in both the US and Switzerland regions.

detail

ePHI in transit between clients and the platform is protected by TLS, which provides confidentiality and integrity over the connection. HDS operates the certificate lifecycle and serves only encrypted endpoints. The implementer's obligation is to ensure that its own onward transmission paths (any proxy or integration hop it controls) preserve the same protection.

  • 🔒 hipaa/policies/transmission-security available on request
Implementer
covered-entity documented

Ensure your client and any onward integration hops you control transmit ePHI only over TLS; document the transmission-security boundary.

business-associate documented

Same — preserve TLS across any transmission path you operate.

individual out-of-scope

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

Implement security measures to ensure that electronically transmitted ePHI is not improperly modified without detection until disposed of.

Pryv platform implemented

TLS 1.3 provides cryptographic integrity (AEAD) on every byte in transit. End-to-end transmission integrity is therefore a property of the connection — modification in transit is cryptographically detectable. Endpoint-to-endpoint integrity across multiple hops (e.g., proxy chains) requires the implementer's chain to preserve this property.

HDS implemented USCH

TLS provides cryptographic integrity on every byte in transit, so modification of ePHI on the connection to the HDS-operated platform is cryptographically detectable. End-to-end integrity across any additional hops depends on the implementer's chain preserving the same property.

detail

The transmission-integrity specification is met on the platform connection by the authenticated-encryption guarantees of TLS: in-transit tampering breaks the connection's integrity check. HDS operates this for all served endpoints. Where an implementer routes ePHI through intermediate hops it controls, it must ensure those hops do not terminate and re-emit traffic in a way that loses the integrity guarantee.

  • 🔒 hipaa/policies/transmission-security available on request
Implementer
covered-entity documented

Preserve transmission integrity across any hops you operate, and document the addressable decision.

business-associate documented

Same — maintain integrity guarantees across your own transmission chain.

individual out-of-scope

164.312(e)(2)(ii) Encryption — Addressable (transmission) draft

Implement a mechanism to encrypt ePHI whenever deemed appropriate.

Pryv platform implemented

TLS 1.3 in transit is default-on via the built-in ACME integration; mTLS between cores is the inter-node default once a cluster is bootstrapped. "Whenever deemed appropriate" — Pryv's default for ePHI transit is: always.

HDS implemented USCH

Encryption of ePHI in transit is default-on: the HDS-operated platform serves only TLS-encrypted endpoints, so the "whenever deemed appropriate" judgement is resolved to "always" for transmission. This row covers transmission only; at-rest encryption is addressed under §164.312(a)(2)(iv).

detail

For ePHI in transit, HDS's default is to encrypt every connection via TLS, satisfying the addressable transmission-encryption specification without requiring an implementer decision to enable it. HDS operates the certificate lifecycle. The implementer documents that transmission encryption is in force and, separately, assesses at-rest encryption under §164.312(a)(2)(iv), where the platform gap is noted.

  • 🔒 hipaa/policies/transmission-security available on request
  • 🔒 hipaa/policies/encryption available on request
Implementer
covered-entity documented

Document that transmission encryption is in force; separately address at-rest encryption per §164.312(a)(2)(iv).

business-associate documented

Same — record the transmission-encryption posture and address at-rest separately.

individual out-of-scope

164.314(a)(1) Business associate contracts — Organizational requirement draft

A covered entity is not in compliance unless it has obtained satisfactory assurances, via a written contract, that the business associate will appropriately safeguard the ePHI it creates, receives, maintains, or transmits on the covered entity's behalf.

Pryv platform facilitated

The BAA itself is a contract — the covered entity drafts it with legal counsel. What Pryv contributes when you operate as a business associate: the audit log makes "implement administrative, physical and technical safeguards" (§164.314(a)(2)(i)(A)) auditable per the BAA's specified terms; the access primitive bounds which subjects + which streams the BA may touch; CMC's cross-platform consent flow gives a structured channel for the §164.314(a)(2)(i)(C) breach-notification pipe between BA and CE.

HDS facilitated USCH

HDS provides a Business Associate Agreement template and the technical assurances (audit, access control, monitoring, regional residency) that back it, and signs BAAs with its own subcontractors. The contract itself is executed between the parties.

detail

When a partner acting as a Covered Entity or upstream Business Associate processes ePHI on HDS, HDS is their Business Associate. HDS offers the BAA template (templates/baa), supplies the technical-safeguards evidence the contract relies on, and flows obligations down to its own subcontractors via back-to-back agreements tracked in the BAA register.

  • 🔒 hipaa/registers/baa-register available on request
Implementer
covered-entity documented 📄 baa

Execute a BAA with HDS before sending any ePHI, and keep it on file.

business-associate documented 📄 baa📄 subcontractor

Execute a BAA with HDS and back-to-back agreements with any of your own downstream processors.

individual out-of-scope

164.314(a)(2)(i)(A) Business associate contract — implement reasonable and appropriate safeguards draft

The business associate contract must require the business associate to implement administrative, physical, and technical safeguards that reasonably and appropriately protect the confidentiality, integrity, and availability of the ePHI it handles on the covered entity's behalf.

Pryv platform facilitated

The BAA's "reasonable and appropriate safeguards" obligation is satisfied by the technical-safeguards programme already enumerated across §164.308 + §164.310 + §164.312. The BA cites the relevant Pryv-implemented rows when populating their BAA exhibit. Mapping this Article to the existing technical-safeguards rows is the `derives_from` chain.

HDS facilitated USCH

The safeguards HDS commits to in its BAA are the same technical and administrative controls enumerated across the §164.308, §164.310 and §164.312 rows of this matrix. The BAA cites that programme so the implementer can populate its safeguards exhibit by reference.

detail

Rather than restating safeguards in prose, HDS's BAA points to the implemented and configurable controls already documented in this matrix — access control, audit logging, encryption, monitoring and regional residency. This gives the contractual "reasonable and appropriate safeguards" clause a concrete, auditable backing.

  • 🔒 hipaa/registers/baa-register available on request
Implementer
covered-entity documented 📄 baa

Confirm that the BAA's safeguards clause reflects the controls you rely on, and retain the safeguards exhibit with the executed contract.

business-associate documented 📄 baa📄 subcontractor

Ensure the safeguards you commit to your covered entity are matched by the controls you and your downstream processors actually operate.

individual out-of-scope

164.314(a)(2)(i)(C) Business associate contract — report security incidents draft

The business associate contract must require the business associate to report to the covered entity any security incident of which it becomes aware, including breaches of unsecured ePHI.

Pryv platform facilitated

Detection of a security incident is the BA's operational concern (audit-log review + observability). Reporting to the CE is the contractual flow. Pryv's CMC plugin provides a structured cross-account messaging substrate when both sides run Pryv — otherwise the report channel is email / API / portal at the BA's choice. The audit log supplies the forensic evidence the report cites.

HDS facilitated USCH

HDS's BAA commits HDS to notifying the implementer of security incidents affecting their ePHI, and HDS's monitoring and incident-response programme supplies the detection and forensic evidence behind that obligation.

detail

Detection rests on the audit log (Pryv layer) plus HDS's infrastructure monitoring with end-to-end alert wiring. When an incident is detected, the BAA's notification clause defines the channel and timing for reporting to the implementer; HDS's incident-response procedure governs how that report is produced and what evidence it carries.

  • 🔒 hipaa/procedures/security-incident-response available on request
  • 🔒 hipaa/registers/baa-register available on request
Implementer
covered-entity documented 📄 baa

Ensure your BAA with HDS specifies the incident-report channel and timing, and integrate HDS reports into your own breach-assessment procedure.

business-associate documented 📄 baa📄 subcontractor

Flow the incident-report obligation through to your covered entity and down to your subcontractors.

individual out-of-scope

164.314(a)(2)(ii)(B) Business associate contract — extend safeguards to subcontractors draft

Where applicable, the business associate must ensure that any subcontractors that create, receive, maintain, or transmit ePHI on its behalf agree, via a written contract, to comply with the applicable Security Rule requirements.

Pryv platform out-of-scope

Subcontracting chains are contractual — no software role. The only built-in subprocessor Pryv-the-software carries is the observability-provider adapter (default disabled); when enabled, the BA's subcontractor list adds the observability provider as a sub-processor under both HIPAA-Security §164.314(a)(2)(ii)(B) and GDPR Art.28(4).

HDS facilitated USCH

Acting as a Business Associate, HDS executes back-to-back agreements with each subcontractor that may touch ePHI and tracks them in its BAA register. HDS also provides the implementer a subcontractor agreement template to flow the same obligations down their own chain.

detail

HDS maintains a current list of its ePHI-relevant subprocessors and holds a written contract with each that flows down the applicable Security Rule obligations. The subprocessor list is made available to implementers so they can satisfy their own §164.314(a)(2)(ii)(B) due diligence.

  • 🔒 hipaa/registers/baa-register available on request
  • 🔒 hipaa/registers/subprocessor-register available on request
Implementer
covered-entity documented 📄 baa

Review HDS's subprocessor list as part of your vendor due diligence.

business-associate documented 📄 subcontractor📄 subprocessor

Execute written agreements with each of your own downstream subcontractors that handle ePHI, flowing the Security Rule obligations through.

individual out-of-scope

164.316(a) Policies and procedures — standard draft

Implement reasonable and appropriate policies and procedures to comply with the standards, implementation specifications, and other requirements of the Security Rule.

Pryv platform out-of-scope

The policies-and-procedures programme is an organizational artefact owned by the covered entity / business associate's security officer. Pryv has no software role in drafting them. Pryv-side documentation (this matrix, CHANGELOGs, the QMS workstream) feeds the operator's policy work but doesn't substitute for it.

HDS documented USCH

HDS maintains its own written information-security policy set covering the Security Rule safeguards for the systems it operates. This governs HDS's role as operator and Business Associate; the implementer keeps its own policy programme for the parts it controls.

detail

HDS's security policies and procedures are owned by its security function and reviewed on a defined cadence. They are referenced throughout this matrix as the administrative backing for the technical controls. The implementer cannot inherit these policies for its own organisation, but can cite HDS's programme where HDS operates the underlying system.

  • 🔒 hipaa/policies/information-security-policy available on request
Implementer
covered-entity documented

Maintain your own reasonable and appropriate policies and procedures for the parts of the system and workflow you control.

business-associate documented

Maintain your own Security Rule policy set covering your handling of ePHI.

individual out-of-scope

164.316(b)(1) Documentation — Required draft

Maintain the policies and procedures implemented to comply with the Security Rule in written or electronic form, and maintain a written or electronic record of any action, activity, or assessment the subpart requires to be documented.

Pryv platform facilitated

Where the required record is operational (activity logs, assessment outputs), Pryv events on a designated `compliance/*` stream carry the documentation alongside the audit log's automatic operational record. Event versioning preserves the change history of policies-as-data; backup-restore preserves them across the §164.316(b)(2) retention window.

HDS documented USCH

HDS keeps its security policies, procedures, registers and assessment outputs in durable written form under a documentation-management policy. Required activity records are retained alongside the audit trail of the systems HDS operates.

detail

HDS's documentation-and-retention policy defines what is documented, where it is held, and how versions are preserved. Operational records (activity reviews, assessments, incident reports) are retained as written artefacts; the per-user audit log (Pryv layer) supplies the automatic operational record. The implementer keeps the equivalent documentation for its own programme.

  • 🔒 hipaa/policies/documentation-and-retention available on request
Implementer
covered-entity documented

Keep your own policies, procedures and required activity records in written or electronic form.

business-associate documented

Maintain written documentation of your Security Rule compliance and the activities the subpart requires you to record.

individual out-of-scope

164.316(b)(2)(i) Documentation — time limit — Required draft

Retain the documentation required by §164.316(b)(1) for six years from the date of its creation or the date when it last was in effect, whichever is later.

Pryv platform facilitated

Six-year is a **minimum** retention period, not a maximum (the statute says "retain … for 6 years"; covered entities may retain indefinitely). Pryv's audit log persists by default; retention beyond the minimum + any operational pruning are operator-driven choices (operator schedules archival to cold storage per their policy). `bin/backup.js` produces the artefact the §164.316 retention rule attaches to.

HDS documented USCH

HDS retains its security documentation and required records for at least six years under its documentation-and-retention policy, treating six years as a regulatory floor rather than a destruction deadline.

detail

The six-year minimum applies to HDS's own policies, procedures and assessment records for the systems it operates. Retention beyond the minimum, and any pruning, follow HDS's documented retention schedule. For subject-level data and audit records, retention is configured per the implementer's lawful basis and contractual instructions; the implementer retains its own documentation independently.

  • 🔒 hipaa/policies/documentation-and-retention available on request
Implementer
covered-entity documented

Retain your own Security Rule documentation for at least six years from creation or last-effective date.

business-associate documented

Apply the six-year minimum retention to your own policies, procedures and required records.

individual out-of-scope

164.316(b)(2)(iii) Documentation — updates — Required draft

Review documentation periodically, and update it as needed in response to environmental or operational changes affecting the security of the ePHI.

Pryv platform facilitated

Periodic review cadence is the operator's procedure. Pryv's contribution: when policies- as-data are stored as events on a `compliance/policies/*` stream, the event-version chain shows when each policy was last reviewed and what changed; audit log shows who-reviewed- what.

HDS documented USCH

HDS reviews its security documentation on a defined periodic cadence and updates it in response to changes in its environment or operations. Review dates and changes are tracked so the documentation's currency is demonstrable.

detail

HDS's documentation-and-retention policy sets the review cadence and the triggers (infrastructure change, new threat, incident, regulatory change) that prompt an out-of-cycle update. Each policy and register carries its review history. The implementer runs its own review cycle for the documentation it owns.

  • 🔒 hipaa/policies/documentation-and-retention available on request
Implementer
covered-entity documented

Review and update your own documentation periodically and in response to operational or environmental changes.

business-associate documented

Keep your Security Rule documentation current through periodic and event-driven reviews.

individual out-of-scope