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