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GuardWell Compliance

HIPAA · OSHA · OIG · CMS · MACRA · DEA · CLIA · Allergy · TCPA · State Law

Healthcare compliance
without the complexity

GuardWell Compliance brings 15 compliance modules into one affordable dashboard built for small medical practices — HIPAA, OSHA, OIG, CMS, MACRA, DEA, CLIA, TCPA, allergen safety, state law, training, and more.

7-day free trial · No setup fees · Cancel anytime

15
Compliance modules
127+
Policy templates
49
Training courses
Live preview

Your compliance, at a glance

One real-time dashboard tracks all your modules, flags what's due, and tells you exactly where your practice stands — updated daily.

v2.app.gwcomp.com/dashboard

Metro Family Medicine

Compliance Dashboard · Family Practice

Compliant

Overall Score

84%

Compliant

+3 pts this week

HIPAA

87%

OSHA

92%

OIG

76%

State Law

81%

CMS

74%

Training

88%

Policies

83%

Risk

79%

Credentials

95%

Vendors

90%

DEA

85%

CLIA

91%

Allergy

89%

TCPA

78%

MACRA

82%

Action Items

HIPAA SRA due in 14 days

2 staff haven't completed OSHA training

Bloodborne Pathogen policy expires in 30 days

Interactive preview of the GuardWell Compliance interface. Start your free trial to use the real thing.

Industry data

Why compliance can't wait

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

725

healthcare data breaches reported to HHS in 2024

More than two large PHI breaches per day

HIPAA Journal 2024 Healthcare Data Breach Report (HHS-OCR data)

$2.3M

average cost of a HIPAA violation

OCR enforcement actions continue to rise

HHS-OCR resolution agreements, 2020-2024

70%

of practices fail their first OSHA inspection

Most violations are easily preventable

OSHA inspection data summary

40%

increase in Medicare audits since 2023

CMS Recovery Audit programs expanding

CMS RAC program reports

15 Compliance Modules

Every regulatory requirement, in one place

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.

120+ 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

Cross-cutting overlay layer that activates state-specific rules across HIPAA, OSHA, OIG, and the other 8 federal frameworks — breach notification deadlines, retention windows, mandatory-reporting thresholds. Top-10 states (CA, TX, FL, NY, PA, IL, OH, GA, NC, MI) get deep rule overlays; the other 40 states + DC have foundational coverage and per-state landing pages.

Overlay across all 50 states + DC

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, suggested 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 and lab staff training for in-house labs. Covers waived and non-waived CLIA certificates.

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

49+ 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.

49+ courses with scenario quizzes

Policy Library

120+ 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 and quality-measure submissions, and keep your MIPS reporting documented year-round so you're prepared before the deadline.

Stay MIPS-ready year-round

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

How it works

Up and running in under an hour

No consultant required. No long implementation projects. Just compliance.

01

Onboard in 5 minutes

Enter your practice details, then activate the compliance modules that apply to you — HIPAA, OSHA, DEA, Medicare, and more. Each toggle explains what it does and why it matters.

02

Activate your modules

Assign training to staff by role, activate policies for acknowledgment, complete your HIPAA SRA, and start checking off items across all 15 compliance modules.

03

Monitor, report & remediate

Your compliance score updates daily. Automated email reminders keep staff on track. Generate audit-ready PDF reports in one click.

Pricing

Simple, transparent pricing

One plan. Everything included. No per-user fees.

Save 20%
7-day free trial

GuardWell Compliance

Unlimited staff

Full compliance suite — all 15 modules including HIPAA, OSHA, OIG, CMS, DEA, CLIA, MACRA, TCPA, and Allergen Safety, with AI-powered tools

$199/month
$249/mo(billed annually at $2388/yr)
  • Unlimited team members
  • 15 compliance modules
  • AI Compliance Concierge — unlimited
  • AI Policy Personalization Engine
  • Breach Decision Wizard + State Deadlines
  • 49+ Training Courses with scenario-based quizzes
  • 120+ Policy Templates with AI Personalization
  • Incident Tracking, SRA & Audit Package PDF
  • Credentials Vault & BAA Management
  • OIG / LEIE Sanctions Screening (monthly)
  • AI Regulatory Intelligence & Weekly Digest
  • Audit Prep packets + annual auto-creation
  • 15 GB document storage

Plus AI Concierge deep-links, weekly regulatory digest & more

7-day free trial · No setup fees · Cancel anytime

Prices in USD, billed annually. Flat rate — no per-user fees.

Everything included

Every GuardWell plan includes all 15 modules and every tool below — one flat rate, unlimited staff, no per-module add-ons.

Compliance Modules

  • HIPAA (Privacy, Security, Breach)
  • OSHA Safety
  • State Privacy Laws
  • OIG Compliance Program
  • CMS / Medicare
  • DEA Compliance
  • CLIA Lab Compliance
  • MACRA / MIPS Tracker
  • TCPA Patient-Outreach Policies
  • Allergen Safety (USP-797 + Anaphylaxis)

Audit & Sanctions

  • OIG / LEIE Sanctions Screening · monthly
  • Audit Prep packets · annual auto-creation
  • Investigation Response (OCR/OSHA letter mode)

Training & Policies

  • Staff Training Courses
  • Policy Templates
  • Risk Assessment (SRA)

AI & Advanced Tools

  • AI Concierge · unlimited
  • AI Policy Personalization Engine
  • Breach Decision Wizard
  • Audit Package PDF

Pricing & Trial

  • Free trial · 7 days

21 features, one plan. Start your 7-day free trial →

FAQ

Frequently asked questions

Everything you need to know about GuardWell Compliance.

GuardWell Compliance is an all-in-one healthcare compliance management platform built specifically for small and mid-size medical practices. It covers 15 compliance modules — including HIPAA, OSHA, OIG, CLIA, MACRA/MIPS, DEA, CMS, TCPA, allergen safety, and state law — in a single dashboard with guided workflows, policy templates, staff training, risk assessments, and incident tracking.

GuardWell is designed for independent medical practices with 1–25 providers — including primary care, dental, chiropractic, mental health, physical therapy, and urgent care offices. It is built for practice owners, office managers, and practice administrators who are responsible for compliance but do not have a dedicated compliance department.

GuardWell covers HIPAA (Privacy Rule, Security Rule, and Breach Notification), OSHA workplace safety, OIG compliance programs, CLIA laboratory compliance, MACRA/MIPS improvement activities, DEA controlled substance requirements, CMS Medicare compliance, TCPA patient-outreach policies, allergen safety and anaphylaxis emergency response, state law overlays for all 50 states + DC, and staff compliance training and certification tracking.

GuardWell is a single all-inclusive plan at $249/month ($199/month with annual billing) for unlimited staff. Every feature is included — all 15 compliance modules, AI tools, training courses, policy templates, and audit reports. Start with a 7-day free trial (card required, no charge for 7 days). There are no per-user fees, no setup fees, and no long-term contracts.

GuardWell is designed to handle the day-to-day compliance management that practices typically rely on consultants or spreadsheets to manage — policy tracking, training assignments, risk assessments, incident logging, and audit preparation. Many practices use GuardWell alongside a compliance consultant for complex regulatory questions, while others find that the platform's guided workflows and 120+ policy templates reduce or eliminate the need for routine consulting.

Yes. GuardWell is built on HIPAA-compliant infrastructure with AES-256 encryption at rest, TLS 1.2 or higher encryption in transit, role-based access controls, and audit logging. We execute Business Associate Agreements (BAAs) with all subprocessors and customers. Our platform is designed to meet the administrative, physical, and technical safeguard requirements of the HIPAA Security Rule.

Most practices complete onboarding in 5–10 minutes. You’ll enter your practice info, choose your HIPAA and OSHA types, toggle on the compliance modules that apply to you, and select your plan. Once inside, a guided setup dashboard walks you through completing your profile, adding team members, and activating your compliance program step by step.

GuardWell monitors regulatory changes across all covered compliance domains. When HIPAA, OSHA, or other regulations are updated, we update the affected policy templates, training content, and compliance checklists within the platform and notify your practice so you can review and adopt the changes. You do not need to track regulatory updates yourself.

Yes. GuardWell includes several AI-powered features to accelerate compliance work. AI Incident Triage analyzes plain-English descriptions of incidents and automatically classifies them by type, severity, and PHI involvement. AI Corrective Action Plans generate detailed remediation steps for high-risk items in your Security Risk Assessment. Automatic Policy Gap Detection scans your adopted policies quarterly and notifies you of missing, unacknowledged, or stale policies. The AI Concierge answers compliance questions in natural language. All AI features are designed as suggestions that you review before applying — GuardWell never takes automated action on your behalf.

Yes. GuardWell supports multi-state compliance for practices that operate in multiple states — including telehealth providers and multi-location groups. Configure your primary state and any additional operating states in Settings, and GuardWell auto-activates the relevant state-specific requirements for privacy, breach notification, OSHA, mandatory reporting, records retention, and more. The breach wizard calculates per-state notification deadlines and shows you the earliest deadline across all applicable states.

GuardWell generates several audit-ready reports. The Audit Package is a comprehensive 10-page PDF covering all compliance modules — ideal for HIPAA audits, board reviews, or insurance renewals. OSHA Forms 300, 300A, and 301 are generated directly from your incident data. Training certificates include QR codes for digital verification. The Security Risk Assessment exports as a printable report. The Activity Log provides a complete audit trail of all compliance actions taken by your team.

GuardWell's AI Regulatory Intelligence Engine monitors eight federal agency feeds daily — including the Federal Register for HHS, CMS, OSHA, and DEA, plus OIG reports and CMS MLN Connects. AI analyzes each article against your full compliance profile, filters out irrelevant content, and drafts specific platform updates: revised checklist items, policy template edits, threshold changes, and customer notifications. Approved changes are applied automatically and flow into your weekly digest email.

The proposed HIPAA Security Rule update (NPRM published January 6, 2025) would introduce significant new requirements for healthcare organizations, including mandatory technology asset inventories, network mapping with ePHI data-flow documentation, penetration testing and vulnerability scanning, and business associate technical verification. GuardWell helps you get ready: a 35-question Tech Assessment that surfaces gaps in technical safeguards, the vendor + BAA register with technical-verification fields, a Document Hub where you store pen-test reports, vulnerability scans, and ePHI data-flow diagrams as evidence, new policy templates aligned with the proposed rule, and a corrective-action register that tracks remediation from finding to close. Note: GuardWell stores the artifacts and tracks the program — your outside cybersecurity firm runs the actual pen tests and produces the network-map diagrams.

HHS published a proposed rule (NPRM) on January 6, 2025, with a final rule expected in 2026. Once finalized, covered entities will likely have 180 days to comply. GuardWell helps you start building your compliance program now — including the Tech Assessment, vendor BAA verification, evidence storage, and corrective-action tracking — so you are well ahead of the deadline.

Yes. For policies assigned to all staff or role-specific groups, an administrator must review and acknowledge the policy first. This ensures management has signed off on the official version before staff are asked to accept it. Staff members see a clear 'Pending admin review' status until the admin releases the policy. Admin-only policies do not require this step.

GuardWell automatically saves your quiz progress after every answer. If you close the browser, lose your connection, or need to step away, your answers are preserved. When you return, you'll resume exactly where you left off — no need to start over.

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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