HIPAA Compliance That Produces Evidence, Not Just Checklists

Name: AlignSure HIPAA Compliance
Brand: AlignSure
Price: 1500 USD
Availability: InStock

Track every Business Associate Agreement. Automate breach notification workflows. Generate documentation that satisfies OCR auditors, not just your internal checklist.

Request a Demo

AlignSure BAA review with METIS AI surfacing missing provisions and reviewer attestation history

The Problem

What regulated organizations face today

Healthcare organizations manage dozens to hundreds of vendor relationships involving protected health information. Most track BAAs in spreadsheets, filing cabinets, or scattered SharePoint folders. When OCR comes knocking, assembling evidence takes weeks. Breach notification timelines get missed because nobody owns the workflow. Risk assessments are snapshots that go stale the day they're completed.

The real cost is not the fine. It's the operational chaos between audits. Staff hours burned chasing attestations. Vendors operating without current BAAs. Security incidents without documented response procedures. Every gap is potential liability that compounds until someone asks for proof.

By the Numbers

HIPAA enforcement at a glance

$2.1M

Average OCR resolution agreement amount

725+

Breach investigations opened annually by OCR

60 days

HITECH breach notification deadline to individuals

100%

Of vendors handling PHI require an executed BAA

Sources: HHS Office for Civil Rights enforcement data; HITECH Act §13402

The Solution

How AlignSure solves it

BAA Lifecycle Management

Track every Business Associate Agreement from execution through renewal and termination. Automated expiration alerts. Version history with signer attestation. Complete audit trail of every BAA interaction.

Breach Notification Workflows

Structured incident response workflows aligned to HITECH breach notification timelines. Identity-bound documentation of every step. Automated escalation when deadlines approach. Evidence packages ready for HHS reporting.

Risk Assessment Documentation

Continuous risk assessment evidence collection, not annual snapshots. Map controls to HIPAA Security Rule requirements. Document safeguards with automated evidence from your Microsoft 365 environment.

Vendor Compliance Tracking

Monitor Business Associate compliance status across your entire vendor network. Track attestations, security questionnaire responses, and compliance certifications. Flag vendors with expired or missing documentation.

Features

Key platform capabilities

BAA execution tracking with signer identity verification

Automated expiration and renewal alerts

Breach notification timeline management (HITECH 60-day compliance)

HIPAA Security Rule control mapping

Risk assessment evidence collection

Vendor compliance status dashboard

PHI access logging and minimum necessary enforcement

OCR audit evidence export packages

Evidence

What your auditor, underwriter, or regulator receives

Complete BAA inventory with execution dates, signers, and renewal status
Breach notification timeline documentation with identity-bound actions
Risk assessment reports mapped to HIPAA Security Rule requirements
Vendor compliance attestation records
Access control documentation with Microsoft Entra ID integration

Coverage

Regulatory frameworks addressed

HIPAA Privacy Rule (45 CFR Part 160, Subparts A & E of Part 164) HIPAA Security Rule (45 CFR Part 160, Subparts A & C of Part 164) HITECH Act Breach Notification Requirements HHS Office for Civil Rights (OCR) Audit Protocols State Health Data Privacy Laws

FAQ

Frequently asked questions

What is a Business Associate Agreement (BAA)?

A Business Associate Agreement is a legally required contract under HIPAA between a covered entity and any vendor or partner that creates, receives, maintains, or transmits protected health information (PHI) on its behalf. The BAA establishes permitted uses and disclosures of PHI, requires appropriate safeguards, and defines breach notification obligations.

What are the penalties for HIPAA non-compliance?

HIPAA penalties range from $141 to $2,134,831 per violation depending on the level of negligence, with an annual maximum of $2,134,831 per identical provision. The HHS Office for Civil Rights (OCR) enforces penalties through investigations, corrective action plans, and resolution agreements. Criminal penalties can include fines up to $250,000 and imprisonment.

When is breach notification required under HITECH?

Under the HITECH Act, covered entities must notify affected individuals within 60 days of discovering a breach of unsecured PHI. If the breach affects 500 or more individuals, the covered entity must also notify HHS and prominent media outlets in the affected jurisdiction. Business associates must notify the covered entity within the timeframe specified in their BAA, typically within 30 days.

What does the HIPAA Security Rule require?

The HIPAA Security Rule (45 CFR Part 164, Subparts A and C) requires covered entities and business associates to implement administrative, physical, and technical safeguards to ensure the confidentiality, integrity, and availability of electronic PHI. This includes conducting risk assessments, implementing access controls, maintaining audit logs, and establishing contingency plans.

How often should HIPAA risk assessments be performed?

HIPAA does not specify a fixed frequency for risk assessments, but OCR guidance recommends conducting them regularly and whenever significant changes occur to an organization's environment, operations, or technology. Most compliance frameworks recommend annual risk assessments at minimum, with continuous monitoring of controls between formal assessments.

Differentiation

Operational HIPAA Management, Not Just Technical Controls

Many compliance platforms approach HIPAA as an IT security checklist: vulnerability scans, access logs, encryption verification. Those controls matter, but they cover only the Security Rule. Healthcare organizations also need to manage Privacy Rule obligations: BAA lifecycles across dozens of vendors, breach notification workflows with HITECH 60-day timelines, workforce training documentation, and minimum necessary access enforcement. AlignSure manages the full operational scope of HIPAA: Privacy Rule, Security Rule, and HITECH Act, with identity-bound evidence that connects compliance activity to your existing Microsoft 365 environment. The result is documentation that satisfies OCR auditors, not just your IT security team.

Ready to see it?

Request a demo configured for your organization's specific compliance requirements.

Request a Demo View All Solutions