GuardWell Compliance Features

15 Compliance Modules

Every regulatory requirement, covered

Built for the realities of medical practice compliance — not generic business software. Each module maps to real federal and state requirements.

HIPAA Compliance

Full HIPAA Privacy & Security Rule compliance — Tech Assessment, vendor BAA verification, breach notification workflows, annual SRA, and a Document Hub for evidence. Built to get ahead of the proposed Security Rule overhaul.

130+ policy templates

OSHA Safety

Bloodborne pathogens, HazCom 2012, emergency action plans, and injury/illness logs. Pre-built checklists for any clinic setting.

4 sub-modules: BBP, HazCom, EAP, Safety

OIG Compliance Program

All 7 elements of an OIG-compliant healthcare compliance program, plus monthly LEIE / sanctions screening of every staff member and vendor.

7-element program + monthly LEIE screening

State Law Overlay

Multi-state compliance engine — configure your operating states and auto-activate state-specific breach notification, retention, and mandatory-reporting rules. Top-10 states (CA, TX, FL, NY, PA, IL, OH, GA, NC, MI) include deep rule overlays; the other 40 states + DC have foundational coverage and per-state landing pages.

All 50 states + DC supported

Risk Assessment (SRA)

Guided annual HIPAA Security Risk Assessment with risk scoring, AI-generated corrective action plans, and remediation tracking. Generate audit-ready SRA reports and comprehensive audit packages.

AI corrective action plans + audit package

Incident Management

Log, investigate, and track security incidents with AI-powered triage, automated severity classification, guided investigation workflow checklists, corrective action plans, and OSHA Forms 300/300A/301 generation.

AI triage + guided investigation workflow

Credential Tracking

Track provider licenses, certifications, DEA registrations, and insurance credentials with automated expiry alerts so nothing lapses.

Auto expiry alerts + renewal reminders

Vendor & BAA Management

Track business associate agreements, vendor risk assessments, and third-party compliance status. Automated reminders for BAA renewals and annual reviews.

BAA tracking + vendor risk scores

CLIA Lab Compliance

Certificate tracking, quality control documentation, and lab director requirements. Covers waived and non-waived in-house labs.

Waived & non-waived lab coverage

Allergen Safety & Anaphylaxis

USP-797 allergen-compounding rules, anaphylaxis emergency response drills, in-house allergen-equipment checks, and a guided staff competency program. For practices that compound, dispense, or administer high-risk allergens.

USP-797 + anaphylaxis drills

Staff Training LMS

36+ professionally written compliance courses with scenario-based quizzes, auto-assignment by role, quiz progress auto-save, and category/status filters. Admins can manage due dates and view completed courses at a glance. Printable certificates for every staff member.

36+ courses with scenario quizzes

Policy Library

130+ compliance-focused templates your team can customize, e-sign, and track. Admin-first acknowledgment ensures management signs off before staff are asked to accept. Linked directly to checklist items across all modules so you always know which policy closes a gap. Automatic gap detection notifies you of missing or stale policies.

E-sign + admin-first acknowledgment

MACRA / MIPS Tracker

Track improvement activities, quality measure submissions, and estimate your annual MIPS performance adjustment before the reporting deadline.

Estimate your MIPS score before deadline

DEA Compliance

9-item controlled substance compliance checklist covering DEA registration, biennial inventory, physical security, and EPCS audit requirements.

9-item controlled substance checklist

CMS / Medicare Compliance

PECOS enrollment tracking, Stark Law & Anti-Kickback disclosures, billing compliance audit, and emergency preparedness documentation for Medicare-participating practices.

PECOS, Stark Law, Anti-Kickback tracking

TCPA Patient-Outreach Policies

TCPA-aligned policy templates and staff training for practices that contact patients by phone or text. Documents your marketing-call procedures so you can show a defensible posture if challenged.

Policy templates + staff training

Why compliance can't wait

The regulatory landscape is getting tougher. These numbers show why proactive compliance management isn't optional.

93%

of healthcare orgs experienced a data breach

in the past 3 years

$2.3M

average cost of a HIPAA violation

OCR enforcement actions continue to rise

70%

of practices fail their first OSHA inspection

Most violations are easily preventable

40%

increase in Medicare audits since 2023

CMS Recovery Audit programs expanding

Feature FAQs

Common questions about GuardWell's compliance modules, AI Concierge, and how the platform compares to alternatives.

GuardWell covers HIPAA Privacy & Security, OSHA workplace safety, OIG 7-element compliance, CLIA laboratory, MACRA/MIPS improvement activities, DEA controlled substances, CMS Medicare, TCPA patient outreach, allergen safety, state law overlays for all 50 states + DC (with deep rules for the top 10 by population), staff training & certification, security risk assessments, incident management & breach triage, OSHA forms 300/300A/301 generation, and a policy library with e-signatures.

GuardWell is purpose-built for small and mid-size medical practices — typically 1 to 50 clinical staff. The platform's depth (analyzer, breach calculator, regulatory intelligence engine, audit packets) was originally built for compliance officers at larger groups, but the pricing and onboarding are calibrated for solo practices and small groups. Flat-rate pricing means a 3-person practice and a 30-person practice pay the same.

For most small practices, yes. The platform automates the year-round work that previously justified a consultant: SRA documentation, policy maintenance, training tracking, breach response, vendor BAA management, and audit packet preparation. Practices with unusual risk profiles (large research datasets, complex multi-entity structures, recent OCR enforcement) typically still benefit from periodic consultant review, but the platform substantially reduces ongoing compliance overhead.

Three differences: (1) flat-rate pricing with no per-user fees, so cost doesn't scale linearly with staff count; (2) the AI Concierge runs on Claude Sonnet 4.6 and reads your live compliance data — it answers with your specific gaps, not generic regulation summaries; (3) the 15-module catalog includes things like state law overlays for the top-10 states, OIG/LEIE monthly sanctions screening, and the breach calculator with state-specific deadlines, which most competitors leave to add-on modules or consultant engagement.

The Concierge has read-only access to your live compliance data — open incidents, SRA findings, training assignments, expiring credentials, recent regulatory alerts — and answers questions in plain English with specific links into the rest of the app. Ask 'what's my next HIPAA gap?' and it surfaces your highest-risk SRA finding with the corrective-action plan deep-linked. Unlimited Concierge queries are included.

Yes. State law overlays are included as a core module. The platform tracks breach-notification deadlines, AG-notification thresholds, medical-records retention rules, mandatory reporting obligations, and PDMP requirements for all 50 states + DC, with hand-curated depth on the top 10 by population. The breach calculator surfaces the operative deadline based on affected residents' states automatically.

Onboarding takes about 30 minutes for the core setup and runs as a first-run wizard inside the app. You'll add your practice profile, invite staff (bulk invite supported), pick a security officer designation, and connect any BAA-relevant vendors. The app then runs an initial risk assessment, assigns role-based training, and surfaces your first set of compliance gaps with prioritized corrective actions.

All-in-one healthcare compliance, finally simple

HIPAA, OSHA, OIG, DEA, MACRA, allergen safety, state law — purpose-built for small and mid-size medical practices. Start your 7-day free trial today.

$199/mo with annual billing · 7-day free trial · Cancel anytime

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