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For healthcare software & health IT teams

Software that touches patient data has to prove itself.

Modern Requirements gives healthcare software teams their compliance record inside Azure DevOps — HIPAA safeguards traced to controls, ONC certification criteria traced to test evidence, FHIR API scope traced to release — in the environment your engineers already work in. AI-native by default.

Modern Requirements4DevOps · Copilot4DevOps · Agents4DevOps — for EHR-adjacent, payer, digital health, and certified health IT programs.

HIPAA Security & PrivacyONC §170.315 · HTIInfo Blocking · 45 CFR 171CMS-0057-FHL7 FHIR · USCDIFDA CDS GuidanceSOC 2 · HITRUST
COMPLIANCE RECORD · patient-portal release 4.2 LIVE · NOT RECONSTRUCTED
RK
RISK-031 · Risk analysis finding
ePHI in transit unencrypted on legacy endpoint · §164.312(e)
MITIGATED
SR
SR-114 · Safeguard requirement
TLS 1.3 enforced on all ePHI-bearing endpoints
APPROVED
API
API-042 · FHIR endpoint
Patient Access API · US Core / SMART v2 scopes
IMPLEMENTED
TS
TEST-208 · Conformance test
§170.315(g)(10) suite · 41/41 passed
PASSED
EV
EVI-208 · Evidence
Test report + config snapshot + reviewer sign-off
LOCKED
✓ e-signed — Compliance Lead · v4.2 baseline Evidence assembled in 0 days — it was never disassembled.
2026-07-14 09:12M. Okafor (Security) created RISK-031 from annual risk analysis v1
2026-07-14 11:47D. Tran (Engineering) linked SR-114 as mitigation · impact scan: 3 items v1
2026-07-15 15:03D. Tran revised SR-114 acceptance criteria after review comment v2
2026-07-16 10:26Pipeline attached TEST-208 results · 41/41 passed run 1841
2026-07-16 16:58A. Reyes (Compliance) e-signed review · meaning: approved for release v2
2026-07-16 17:00System locked EVI-208 into baseline release-4.2 · record immutable BL-42
HIPAA §164.312 technical safeguards24/24 traced
ONC §170.315(g)(10) API criterion41/41 tests linked
USCDI v3 data classes in scope19/19 mapped
Info-blocking exception documentation7/8 documented

Coverage computed from live link data — a query, not a spreadsheet.

The challenge

The regulations move every quarter. The evidence layer was built for none of them.

Healthcare software teams are shipping into the most active regulatory period the sector has seen — new certification criteria in January, enforcement crackdowns in September, API deadlines every January. What breaks first isn't the code. It's the ability to prove the code complies.

$7.42M

Average healthcare breach cost

The costliest industry for data breaches, 14 years running — and OCR's most-cited deficiency is the risk analysis itself.

IBM Cost of a Data Breach 2025
$1M

Per information-blocking violation

Civil monetary penalties for certified health IT developers are now actively enforced — with certification termination on the table.

HHS-OIG · 45 CFR 171
~240days

To comply once the HIPAA update lands

The proposed Security Rule overhaul ends "addressable" safeguards. When it finalizes, the compliance clock is roughly eight months.

HHS NPRM · 90 FR 800
2×/year

Certification attestation windows

Semi-annual ONC attestations, annual real-world testing, and criteria that changed in January — evidence collection never stops.

ONC Health IT Certification Program

Sources as labeled. Regulatory timelines current as of mid-2026 — which is precisely the problem: they won't stay current.

HIPAA · 45 CFR 164.308(a)(1)

A risk analysis that never meets the backlog

The security risk analysis lives in a Word document or a GRC tool. The safeguards it demands live in user stories, config changes, and pull requests — with nothing connecting a finding to the requirement that mitigates it or the test that proves the control works. When OCR investigates, "we have a risk analysis" and "we can show each risk traced to a verified control" are very different answers. The first is the sector's most-cited deficiency.

ONC §170.315 · HTI-1 → HTI-5

Certification evidence scattered across a moving target

USCDI v3 became the baseline in January 2026. HTI-5 proposes removing half the certification criteria. Between rule cycles: semi-annual attestations, annual real-world testing, and Insights Condition reporting. Each cycle, teams rebuild the mapping between criteria, requirements, and test evidence by hand — in spreadsheets that were stale before the last attestation window closed.

FDA CDS Guidance · Jan 2026

AI features shipped without a documented boundary

The FDA's revised CDS guidance makes the device/non-device line a design decision: a non-device CDS function must let the clinician independently review the basis of its recommendation. Teams shipping AI-assisted features rarely document which side of the line each feature sits on — or the design rationale that keeps it there. Drift across that boundary isn't a paperwork problem; it's an unplanned FDA program.

CMS-0057-F · HL7 FHIR

API scope that outruns its own record

Payer and provider-facing teams are building four mandated FHIR APIs against a January 2027 deadline, on implementation guides that version faster than internal documentation. Which USCDI data classes are in scope, which Da Vinci profiles are implemented, which SMART scopes are granted — the answers live in engineers' heads and Confluence pages, not in a record that survives an audit or a staff departure.

Next: the risk loop that never closes, and the regulatory calendar with a clock on it.

Next: The lifecycle →

The lifecycle

Compliance in healthcare isn't a project. It's a loop with a clock on it.

Two lifecycles run a health system's software compliance: the risk-management loop that never closes, and the regulatory calendar that never stops adding deadlines. Modern Requirements runs both on the same live record — so when a rule lands, the clock starts on implementation, not on archaeology.

45 CFR 164.308(a)(1)
Security risk
management
01
Asset & ePHI flow inventory
02
Threat & vulnerability identification
03
Risk assessment
04
Safeguard implementation
05
Evidence & verification
06
Kontinuierliche Überwachung

The loop OCR investigations turn on

Risk analysis remains the most-cited deficiency in OCR enforcement — not because health systems skip it, but because the analysis lives in a document while the safeguards live in a backlog, and the two meet only in audit season.

In Modern Requirements, every station of this loop is a governed work item: the finding traced to the safeguard requirement that addresses it, the control that implements it, and the verification evidence that proves it works. When post-incident review or continuous monitoring reopens a risk, the loop re-enters with its full history — analysis, decisions, signatures — on one thread.

See the governed workflows →

The regulatory calendar, 2026 → 2027

Every card below starts or advances a compliance clock. The proposed Security Rule alone would end "addressable" safeguards — encryption, MFA, asset inventory, and 72-hour recovery become required — with roughly 240 days from publication to compliance for most provisions. A record you can query is the difference between a program and a scramble.

LIVE · JAN 2026
HTI-1 in force

Certification & transparency requirements live; enforcement discretion ended Mar 1

LIVE · FEB 2026
42 CFR Part 2

Updated privacy practices required for substance-use-disorder records

EXPECTED · AUG 2026
Privacy Rule final

OCR moving ahead separately on Privacy Rule changes

DEADLINE · JAN 1 2027
CMS-0057 FHIR APIs

Four FHIR APIs due for impacted payers — build & attest

TARGET · JUL 2027
Security Rule final

OMB agenda target for the first major overhaul in 20+ years; 4,700+ comments in review

PUBLICATION + ~240 DAYS
Compliance due

Effective in 60 days; most provisions require compliance ~180 days after

THE COMPLIANCE CLOCK · EVERY DEADLINE QUERIES THE SAME RECORD2026 → 2027+
⌕

Why the record matters more than the rule: OCR enforcement isn't waiting for the final rule — investigations continue against the current Security Rule, where risk analysis is the most-cited gap. Health systems that keep requirements, safeguards, and evidence on one live thread don't re-platform when a rule lands; they run a gap query, stage the new requirements, and let the same workflows carry them to the deadline.

Next: the five governed workflows that run the loop day to day.

Next: Workflows →

Governed workflows

Five workflows that run a healthcare software program

Each workflow is enforced inside Azure DevOps. Every state has an owner, every transition has a rule, and every approval is logged with an immutable audit trail. They ship as the healthcare configuration of Modern Requirements4DevOps — the operating structure a deployment starts from.

WORKFLOW 01

Security risk analysis & remediation

HIPAA · 45 CFR 164.308(a)(1)

The workflow OCR investigations turn on. Every risk-analysis finding becomes a governed item traced to the safeguard requirement that addresses it, the control that implements it, and the evidence that proves the control works — closing the gap between the risk analysis document and the engineering backlog.

Sicherheit
Finding identified

Threat/vulnerability logged with affected assets and ePHI flows

→
Security + Compliance
Risk assessed

Likelihood × impact scored against your risk framework

→
CISO
Determination

Mitigate, accept, or transfer — rationale recorded

→
Engineering
Safeguard derived

Requirement written, linked to finding and control

→
Engineering
Control implemented

Code/config change linked with requirement ID

→
QA
Evidence verified

Test results and config snapshots attached

→
Einhaltung
Accepted & baselined

E-signed, immutable, ready for any OCR request

Audit standard45 CFR 164.308(a)(1), 164.312
CadenceAnnual analysis + continuous findings
NPRM-readyProposed safeguards staged as draft requirements
WORKFLOW 02

ONC certification & maintenance

§170.315 · HTI Conditions

Certification isn't an event; it's a maintained state. This workflow keeps a live criterion-to-evidence map across rule cycles — new criteria in, retired criteria out — so semi-annual attestations and annual real-world testing draw from current data instead of a rebuilt spreadsheet.

Einhaltung
Criterion scoped

§170.315 criterion mapped to affected modules

→
Product / BA
Requirements derived

Functional and API requirements per criterion

→
Engineering
Developed

Implementation linked to requirement IDs

→
QA
Conformance tested

Test-method evidence captured at execution depth

→
Einhaltung
Certified / attested

Evidence pack exported for the ONC-ACB window

→
Product
Real-world tested

Annual RWT plan and results linked to criteria

→
System
Maintained

Rule change triggers impact scan on the criterion map

Audit standardONC Certification Program · HTI rules
CadenceAttestations 2×/year · RWT annually
Rule churnHTI updates land as scoped impact, not surprises
WORKFLOW 03

CDS & AI feature governance

FDA CDS Guidance · HTI-1 DSI

The critical one for teams shipping AI-assisted features. Every clinical decision support or predictive function is checked against the FDA's non-device CDS criteria before release. Non-device: the basis-transparency the clinician needs is documented and shipped. Device territory: development halts before an unplanned FDA program ships itself. The decision record is permanent either way.

Product
Feature proposed

Intended use, inputs, and clinical role defined

→
Compliance + Clinical
Boundary check

Assessed against non-device CDS criteria, per the Jan 2026 guidance

→
Non-device · Product
Basis documented

Sources, logic, and limitations made reviewable by the clinician; DSI source attributes where certified

Device territory · Compliance
Halted · SaMD path

Development frozen; routed to a regulated-device program

→
Clinical
Reviewed & signed

Clinical reviewer e-signs the boundary rationale

→
System
Released & monitored

Any change to inputs or logic re-triggers the boundary check

Audit standardFDA CDS Guidance (rev. Jan 2026) · HTI-1 §170.315(b)(11)
Re-check triggerAny change to data sources, logic, or presentation
Building a device?See our medical devices microsite
WORKFLOW 04

Interoperability & API lifecycle

CMS-0057-F · HL7 FHIR · USCDI

For the four mandated payer APIs and every FHIR surface you expose. Scope is governed at the data-class level, security at the scope-grant level, and conformance at the test-execution level — so "what exactly does this API share, and can you prove it's conformant?" has a live answer through the January 2027 deadline and beyond.

Product / BA
Scope defined

USCDI data classes and IG profiles per endpoint

→
Engineering
Requirement authored

FHIR R4 / Da Vinci profile requirements per API

→
Engineering
Implemented

Endpoints built; commits carry requirement IDs

→
QA
Conformance tested

Touchstone/Inferno-class results linked at execution depth

→
Sicherheit
Security reviewed

OAuth 2.0 / SMART scopes reviewed and e-signed

→
Product
Published & versioned

Baseline locked per API version

→
System
Change-managed

IG or USCDI version bumps land as impact queries

Audit standardCMS-0057-F · US Core · SMART App Launch
Deadline anchorMandated APIs live by Jan 1, 2027
Scope answerData classes per endpoint — a query, not a meeting
WORKFLOW 05

Change control & release evidence

45 CFR 171 · SOC 2 · HITRUST

The universal workflow every change rides through. Impact is assessed before the change commits; decisions that limit EHI flow carry their information-blocking exception rationale on the record; and every release closes with a locked, exportable evidence trail — the file you want to already have when an investigator, auditor, or customer security team asks.

Any role
Change proposed

Linked to the requirements and obligations it touches

→
System
Impact assessed

Suspect links flag affected safeguards, criteria, and tests

→
Einhaltung
Exception documented

If EHI flow is limited: which 45 CFR 171 exception, and why

→
Approvers
Approved

E-signed with identity, timestamp, and meaning

→
Engineering
Implemented

Change lands; flagged tests re-run

→
QA
Regression verified

Affected conformance and safeguard tests pass

→
System
Released · trail locked

Baseline updated; audit trail immutable and exportable

Audit standard45 CFR 171 exceptions · SOC 2 change management
Enforcement contextInfo-blocking CMPs actively enforced since 2023; escalated 2025
NotificationsOwners alerted at every gate

Next: every framework mapped, obligation by obligation.

Next: Compliance →

Einhaltung

Every framework a healthcare program answers to, mapped to capability

Modern Requirements maps the artifacts in your Azure DevOps environment to the frameworks below — obligation by obligation. When the framework changes, the mapping shows you exactly which requirements it touches.

FrameworkWhat it governsHow it's covered inside Azure DevOps
HIPAA Security Rule
45 CFR 164.308–.312
Administrative, physical, and technical safeguards for ePHIRisk analysis workflow: every finding traced to a safeguard requirement, implemented control, and verification evidence — the trace OCR investigations ask for
HIPAA Security update
NPRM · 90 FR 800
Proposed overhaul: required encryption, MFA, asset inventory, 72-hr recoveryProposed safeguards staged as draft requirements today — when the final rule lands, the ~240-day clock starts against work already scoped
ONC Certification
§170.315 · HTI-1+
Certified health IT criteria, DSI transparency, USCDI, real-world testingCriterion-to-evidence mapping maintained live: requirements, conformance tests, and attestation evidence per criterion, versioned across HTI rule cycles
Information Blocking
45 CFR 171
Practices interfering with EHI access, exchange, or use · $1M CMPsDesign decisions that limit EHI flow captured with their exception rationale documented at the requirement — the defense file, built as you build
CMS-0057-F
Interop & Prior Auth
Four mandated FHIR APIs by Jan 2027; turnaround and reporting rules from 2026API lifecycle workflow: USCDI scope, Da Vinci profiles, SMART scopes, and conformance evidence per endpoint, per version
HL7 FHIR · USCDIUS Core profiles, SMART App Launch, data class scopeData classes and profiles as traceable scope items — a USCDI version bump becomes an impact query, not a re-discovery project
FDA CDS Guidance
Rev. Jan 2026
Device vs. non-device boundary for clinical decision support functionsBoundary-check workflow per feature: non-device criteria assessed, basis-transparency documented, decision e-signed and versioned
SOC 2 · HITRUSTSecurity and trust attestations your customers procure againstControl-to-requirement traceability and audit-ready exports that feed your attestation evidence requests instead of a quarterly scramble
42 CFR Part 2Confidentiality of substance-use-disorder recordsPart 2 handling rules expressed as testable requirements on the data flows they constrain, traced to verification
⇄

Every mapping is bidirectional. Pick an obligation, see which artifacts satisfy it. Pick an artifact, see which obligations it serves. When an OCR investigator, ONC-ACB, or SOC 2 auditor asks "show me," the answer is a filtered view of live data — not a folder someone maintains.

Next: the foundation, the AI layer, and the agents layer.

Next: The platform →

The foundation · Modern Requirements4DevOps

One connected compliance record, from obligation to shipped release

Modern Requirements4DevOps makes every artifact below a real Azure DevOps work item or a Modern Requirements virtual work item. The links are live. Nothing is exported, synced, or reconstructed. And because requirements describe your system — not your patients — no PHI enters the record.

Intelligente Dokumente

The documents a healthcare program actually runs on

Structured, versioned documents built from work items — not Word files pretending to be a system of record. Every clause is a traceable item: security risk analyses, functional and API specifications, certification criteria matrices, CDS boundary rationales, and policy-to-control mappings.

Risk AnalysisFunctional SpecAPI SpecCriteria MatrixCDS RationalePolicy Mapping
Baselines & difference reports

Immutable snapshots at every attestation and release

Snapshot the requirement set at each release, attestation window, and certification event. Locked baselines can never be edited. Compare any two and generate a difference report — exactly the change story an ONC-ACB or auditor asks you to reconstruct, already written.

Per-release baselinesAttestation snapshotsDifference reports
Spurenanalyse

Traceability into test execution, not just test plans

Horizontal traceability and intersection matrices generated in seconds from live link data. Virtual work items extend the trace into execution depth — Test Point, Test Run, Test Result, Test Step Run — so conformance coverage is computed, not claimed. Gaps surface as missing links, not missing spreadsheets.

Trace treeHeatmapCoverage analyticsExecution depth
Review Management & e-signatures

Approvals where the work lives

Structured review workflows with item-by-item navigation, threaded comments, and electronic signatures bound to work-item versions — signer identity, timestamp, and meaning on the record itself. The approval history your compliance program needs, built by the system rather than maintained in a folder.

E-signaturesRole-based accessApproval history

Built inside Azure DevOps. Not integrated with it.

Many requirements tools connect to Azure DevOps. Connection means synchronization — and synchronization is where threads break, records fork, and audit findings are born.

External RM or GRC tool, synced to Azure DevOps

  • Two systems of record; sync jobs decide which one is true today
  • Traceability crosses a tool boundary — matrices exported, screenshotted, rebuilt
  • Separate user store, separate permissions, a second security surface for a security-critical program
  • Evidence assembled per audit or attestation: days of reassembly, every cycle
  • AI experiments live in a third place, outside the record entirely

Modern Requirements, native in Azure DevOps

  • One system of record — requirements are work items, links are link data
  • Traceability spans obligation → requirement → code → test execution in one graph
  • Inherits Azure DevOps identity, permissions, and the platform your team already secures
  • Evidence is continuous: reports generate from live state in minutes
  • AI works inside the same environment — every artifact governed from birth

The AI layer · Copilot4DevOps

Govern the AI. Don't ban it — and don't ignore it.

Your teams are already using AI, and your product probably ships some. The question a compliance program asks isn't "did AI help?" — it's "can you prove what it did?" Copilot4DevOps puts AI-assisted requirements work inside Azure DevOps, so every generated artifact lands in the managed lifecycle with authorship, review, approval, and trace links intact.

Every AI output is a governed work item — reviewable, signable, traceable like anything a human wrote.

Generic AI tools create artifacts outside the record — drafts in chat windows, analyses in documents nobody controls. In a program that answers to OCR, ONC, and its customers' security teams, an artifact that can't be reviewed, signed, and traced doesn't exist as far as an auditor is concerned.

  • Operates within your existing Azure DevOps permissions model — no new access surface for a security-critical program
  • SOC 2 compliant; your data is never used to train models or retained by third-party AI providers
  • Works on requirements and design records — no PHI needed, none stored
  • Every generated artifact carries authorship, version, and trace links from the moment it's created
  • The human stays accountable. The system keeps the receipts.
EL

Elicit & generate

Turn regulatory text, clinical SME interviews, and existing work items into structured requirements — safeguard requirements from a risk finding, functional requirements from a certification criterion, test cases from an API spec — mapped to Azure DevOps items with traceability intact.

AN

Analyze quality before it costs you

Requirements scored against the six C's — clarity, conciseness, completeness, consistency, correctness, concreteness — catching ambiguity before it becomes rework. In a healthcare program, an ambiguous safeguard requirement is a control that can't be verified — which is a finding in waiting.

GA

Gap & compliance checks

Automated analysis flags missing coverage across a document or backlog — risk findings without safeguards, certification criteria without conformance tests, API scopes without security review — the review your team means to do and never has time for.

IM

Impact assessment on live data

Real-time impact analysis over your actual link graph when the ground shifts — a USCDI version bump, an HTI criteria update, a new safeguard from the HIPAA final rule. See every requirement, control, and test the change touches before committing to a timeline.

The agents layer · Agents4DevOps

The routine work of compliance, executed by agents. Humans approve.

Agents4DevOps runs the repetitive, high-volume work a healthcare program generates — evidence assembly, regulatory-change impact mapping, trace patrol — under policy controls you define, with a human decision at every consequential step.

Evidence pack assembly

One prompt. The agent pulls every linked requirement, control, test result, and signed approval for an attestation window, certification event, or audit request, validates the trace, and exports a review-ready pack. The semi-annual attestation scramble becomes a task you run — and re-run before every internal review.

Regulatory-change impact mapping

When a rule moves — an HTI update, a USCDI version, the HIPAA final rule when it lands — the agent maps the change against your criterion and safeguard mappings, flags every affected requirement, and drafts the impact assessment your team refines. The ~240-day compliance clock starts against scoped work, not a blank page.

Trace integrity patrol

Agents patrol the link graph as work happens: risk findings without verified controls, criteria without current test evidence, API changes without security review, suspect links after every change. Gaps are flagged and repair packets drafted — before the gap becomes a finding.

Audit & investigation response prep

When an OCR request, ONC-ACB surveillance query, or customer security questionnaire arrives, the agent assembles the relevant slice of the record — findings, safeguards, evidence, approvals — into a response package a human reviews and sends.

A capacity multiplier for your best people, not a replacement for them. Agents execute under policy controls you define; humans review, decide, and sign. Every agent action runs through the same governed accounts and audit trail as everything else in the system.

Agents4DevOps · attestation evidence pack
› "Assemble the evidence pack for the October attestation window. Validate criterion coverage and flag gaps."
✓ Pulling 894 linked artifacts across 12 criteria
✓ Validating criterion-to-requirement coverage
✓ Verifying conformance test currency per criterion
✓ Checking real-world testing plan linkage
✓ Confirming e-signed approvals on all baselines
⚠ 1 criterion with stale test evidence → flagged for QA
✓ Exporting attestation pack with audit trail
→ Done. Ready for compliance review.
Assembled from live work-item data — requirements, controls, test results, and signed approvals already linked in Azure DevOps. Nothing reconstructed, nothing re-keyed.

Next: what each role does inside the same record.

Next: Who it's for →

Who it's for

One compliance record. Six roles working inside it.

Every workflow on this page has named owners because that's how a healthcare program actually runs — compliance owns the obligations, security owns the risk, engineering owns the implementation. Here's what each role does inside the same system, instead of in six disconnected tools.

Compliance & Privacy

Owns the obligations, without the archaeology

Compliance owns the criterion mappings, exception rationales, attestation calendars, and the answer when a regulator asks. Instead of chasing evidence across teams before every window, compliance works in live views — filter by obligation, see the artifacts that satisfy it, export the pack.

Lives in
Criteria mappingException recordsCompliance viewsEvidence exports
Security / CISO

A risk analysis that actually reaches the backlog

Security owns the findings and the determinations. Every risk traces to a safeguard requirement, an implemented control, and verification evidence — so the answer to OCR's favorite question is a live trace, and the proposed Security Rule's required safeguards are staged as scoped work, not a future crisis.

Lives in
Risk workflowSafeguard traceControl evidenceNPRM staging
Product / BA

Authors the record, not documents about it

Product managers and analysts turn regulatory criteria and user needs into structured requirements in Smart Docs — where every clause is a versioned, traceable item from the moment it's written. Copilot4DevOps drafts derived requirements and flags ambiguity before review, with the author accountable for every accepted output.

Lives in
Smart DocsCopilot elicit & analyzeCriteria derivationReuse library
Engineering

Compliance inside the daily workflow

Developers stay in Azure DevOps — the workflows run through the same boards, repos, and pipelines they already use. Commits carry requirement IDs, test results auto-link, and compliance gates are workflow states rather than meetings. No second tool, no export discipline to maintain.

Lives in
Boards & ReposCode linkingPipelinesWorkflow gates
QA & Test

Coverage that survives requirement change

Conformance and safeguard tests are traceable items linked to the requirements they verify, with the trace extending into execution — Test Point, Run, Result, Step Run. When a requirement or an implementation guide changes, suspect links flag every affected test the moment the change lands.

Lives in
Conformance evidenceExecution traceSuspect linksCoverage analytics
Clinical Informatics

Clinical judgment, on the record

Clinical reviewers own the boundary rationale for CDS and AI features — whether the clinician can independently review the basis of a recommendation, and whether the documentation shipped with the feature makes that possible. Their sign-off is an e-signature on a versioned record, not an email that gets lost.

Lives in
CDS boundary reviewsDSI source attributesClinical sign-offFeature monitoring

Next: guides, blogs and whitepapers to go deeper.

Next: Resources →

Implementation

A use-case-driven rollout, not a platform project

We don't turn on the full platform on day one. The rollout starts with one risk-analysis finding, traced end to end, so the team experiences a real win in the first sprint — and by day 90, holds an evidence pack it can hand to an auditor, an ONC-ACB, or a customer security team.

Weeks 1–2 · Quick win
One finding, end to end
  • Deployed into your existing Azure DevOps tenant
  • One risk-analysis finding traced to a verified control
  • Smart Doc structure mirrored from your current documents
  • First evidence sample in compliance's hands
Weeks 3–4 · Migrate
Risk register & criteria map moved in
  • Full risk register migrated as traceable items
  • Certification criteria matrix live per module
  • Review workflow live with e-signatures
  • First Copilot4DevOps drafts on derived requirements
Weeks 5–8 · Train
Role-based training, four tracks
  • Compliance — obligation views, baselines, exports
  • Security — risk workflow, safeguard traceability
  • Product/BA — Smart Docs, Copilot, criteria derivation
  • Engineering & QA — code linking, execution trace
Weeks 9–12 · Prove
First evidence pack
  • Attestation or audit pack assembled by Agents4DevOps
  • CDS boundary workflow live for AI features
  • Internal mock audit run against the pack
  • Pack exported for your next real window

What "audit-ready" means, measurably

Full bidirectional trace on at least one safeguard family · the complete risk register migrated with the remediation workflow active · and an evidence pack generated from live data that passes an internal mock audit.

The questions strong buyers ask

What a decision maker will want answered before talking to anyone

The questions CISOs, compliance officers, and engineering VPs actually ask when they evaluate a system that will hold their compliance record. Straight answers, including where the honest answer is "that stays in your GRC tool."

Does PHI enter this system? Do we need a BAA?

By design, no PHI should enter the record — and that's a feature, not a limitation. Requirements, risk findings, criteria mappings, and test evidence describe your system, not your patients. Data lives as Azure DevOps work items in your tenant, under your identity model. The deployment guidance explicitly excludes patient data from work items, which keeps this system outside your ePHI boundary and dramatically simplifies its security review. [CONFIRM with product/legal: formal BAA position for customers who request one, and any guardrails offered against inadvertent PHI entry]

Does this replace our GRC platform or compliance automation tool?

No — and the boundary matters. GRC and compliance-automation platforms manage organizational controls: policies, vendor risk, employee attestations, infrastructure monitoring. Modern Requirements is the engineering compliance record: what the software is required to do, why, and the evidence it does it — living where the engineering happens. The two meet at the evidence: safeguard verification, conformance results, and change trails export from live engineering data into your GRC evidence requests. Teams that try to run requirement-level traceability inside an org-level GRC tool are usually the ones rebuilding spreadsheets before every audit.

We're a certified health IT developer. How does this help with attestations and real-world testing?

The certification workflow maintains a live map from each §170.315 criterion to the requirements, implementations, and conformance evidence that satisfy it — versioned across rule cycles. When an attestation window opens, the evidence pack is generated from current data; when the annual real-world testing cycle runs, plans and results link to the same criteria. And when the next HTI rule adds or retires criteria, the change lands as an impact query against the map, not a re-discovery project. [CONFIRM with product: any packaged §170.315 criterion templates shipped with the healthcare configuration]

How does this help with information-blocking exposure?

Enforcement is active, penalties reach $1M per violation for developers, and the defense is documentation: if a design decision limits how EHI is accessed, exchanged, or used, you want the applicable 45 CFR 171 exception and its rationale recorded at the decision, at the time it was made. The change-control workflow captures exactly that — so if a complaint or investigation arrives years later, the contemporaneous record exists. To be precise: this is an engineering documentation capability, not legal advice; your counsel defines which exceptions apply.

We manage requirements in Jira, Excel, or a legacy RM tool. What does moving look like?

Staged, not big-bang. Word and document imports bring structured requirement sets into Smart Docs with hierarchy intact; existing IDs can be preserved as attributes so historical references stay resolvable. Most teams start with the active program — usually the risk register and the current certification criteria map, as in the 90-day rollout above — and leave legacy programs read-only in the old tool until retirement. [CONFIRM with product: current import tooling for Jira and CSV/ReqIF sources]

What are the Azure DevOps prerequisites?

You need an Azure DevOps environment — the platform your software teams are likely already living in. Modern Requirements installs as an extension into your existing organization and projects; requirements become work item types alongside the ones your teams already use, so there's no new user store, login, or permission model to administer — a meaningful point when your security team reviews every new vendor surface. [CONFIRM with product: supported Azure DevOps Services plans, Azure DevOps Server versions, and extension licensing model]

What does an auditor, investigator, or customer security team actually receive?

Documents — because reviews still run on documents. Smart Report and document generation produce Word- and PDF-format outputs from live work-item data: risk-to-control trace matrices, criterion coverage reports, baseline difference reports, and approval histories with signature records (signer identity, timestamp, meaning). The difference from the status quo isn't the format a reviewer sees — it's that the document is a report of the system's state, not a reconstruction of it.

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See it on a program shaped like yours

A working session with our healthcare team — in a demo environment preloaded with a risk register, certification criteria map, FHIR API scope, and CDS boundary records. Your frameworks, your vocabulary, your artifact types.

  • Walk one risk finding end to end: identification → safeguard → verified control → locked evidence
  • See the CDS/AI boundary workflow if AI features are on your roadmap
  • Watch an attestation evidence pack assemble from live work-item data

Prefer to look before you talk? Watch the five-minute technical demo — Smart Docs authoring, live traceability into test execution, and e-signature review workflows, screen-recorded in the live product. Watch the demo — no form →

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Tell us about your program. We'll come prepared with your frameworks, not a generic tour.

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