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Information Security, Risk & Business ContinuityAGS-06-032

HIPAA Privacy, Security & Breach Notification Management System

HIPAA Privacy, Security & Breach Notification Management System

An editable documentation system for HIPAA covered entities and business associates, covering the Privacy Rule, the Security Rule and breach notification in one set.

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121 ready-to-use documents 70 Word · 51 Excel · plus the AGS license · 1 support file

By document type

Total 121
CategoryFiles
Manuals1
Policies4
Procedures & SOPs18
Plans & Programmes4
Forms & Records37
Checklists & Audit Tools19
Registers, Logs & Matrices28
Training & Awareness2
Guides & Work Instructions4
Tools & Workbooks4

Key documents

ReferenceDocumentFormat
HIPAA-MAN-001HIPAA Compliance Governance Manual Word
HIPAA-PRO-003PHI Use and Disclosure Procedure Word
HIPAA-POL-003HIPAA Breach Notification Policy and Procedure Word
HIPAA-PRO-011HIPAA Security Incident Response Procedure Word
HIPAA-FRM-020Breach Risk Assessment Form Word
HIPAA-RA-004HIPAA Risk Analysis Worksheet Excel

Overview

Much HIPAA material in circulation treats proposed rules, or a rule since vacated, as if they were law. This system starts with an applicability assessment, because HIPAA may not apply to you at all, and a regulatory status brief that labels each rule as final, proposed, vacated or recommended practice, as verified in September 2026. The January 2025 Security Rule proposal is described for planning only and is not implemented.

The documents are built against the HIPAA Privacy, Security, Breach Notification and Enforcement Rules at 45 CFR Parts 160 and 164, cited by section and summarised in plain wording. The Notice of Privacy Practices template includes the 42 CFR Part 2 content with a compliance date in February 2026. Work is ordered by the areas the package identifies as OCR enforcement focus: risk analysis, risk management, right of access and timely breach notification. State-law preemption warnings appear where they matter.

A cross-reference to NIST CSF 2.0, NIST SP 800-53 Revision 5 and ISO/IEC 27001:2022 themes helps you reuse security evidence, though framework alignment is not HIPAA compliance. AGS is independent and is not affiliated with HHS, the HHS Office for Civil Rights or NIST. Regulations are referenced by citation. Standards are referenced by number and title only, and no standard text is included.

What this system covers

  • Applicability and governance: covered entity, business associate, hybrid entity and Part 2 record assessments, and a governance manual with Privacy Officer and Security Officer designation.
  • Privacy Rule: a privacy policy, use and disclosure of PHI, minimum necessary, an individual rights procedure with request forms, and a Notice of Privacy Practices template.
  • Security Rule: a security policy, a required versus addressable determination matrix, risk analysis methodology and worksheet, ePHI and system inventories, a risk management plan, and administrative, physical and technical safeguards.
  • Breach notification: incident response, a breach notification policy with four-factor risk assessment and decision records, and a notification letter template.
  • Business associates and continuity: business associate management with a BAA template, subcontractors, a contingency plan, device and media controls and documentation retention.
  • Assessment: gap assessment, a compliance requirements matrix, internal audit, corrective action, risk acceptance, management review and a readiness assessment.
  • Implementation: a 90-day roadmap, compliance calendar, regulatory change register and customisation guide.

Who it's for

HIPAA covered entities (health care providers, health plans and clearinghouses), business associates and subcontractors. A quick start guide helps small practices without dedicated compliance staff. A designated Privacy Officer and Security Officer own the system, with legal counsel on applicability, preemption and notification decisions.

Healthcare entities in Abu Dhabi should see the Healthcare Information & Cyber Security Management System (ADHICS). For a general privacy management system, see the PIMS ISO/IEC 27701 toolkit.

Everything you get

Every toolkit gives you a full set of working documents for your standard, ready to edit and use.

Editable Word and Excel

Native Microsoft files. Add your logo and adapt every document to how you work.

Instant download

Your full toolkit arrives as a ZIP the moment payment clears.

Unlimited users

One purchase covers everyone in your organisation. No per-seat fees.

Written by auditors

Built by people who run real audits, so the content matches what assessors check.

Yours to keep

One payment, perpetual licence for your organisation. No subscriptions, no renewals.

Refund guarantee

Full refund if your files are faulty, incomplete or not as described and we can't put it right

Frequently asked questions

What exactly do I receive?

A downloadable ZIP containing the full set of ready-to-use documents for this toolkit — manuals, procedures, forms, records, checklists, guidance and training material, all in editable Word and Excel format. The exact document count is shown at the top of this page.

Are the documents really editable?

Yes. Every file is native Microsoft Word or Excel — no locked PDFs. Add your logo, change wording, and tailor the content to your organisation. The toolkit is yours to keep and reuse.

Does this certify my organisation?

No. These are documentation toolkits aligned to the relevant standard to help you prepare. Certification itself is issued by an accredited certification body after their audit. Our toolkits give you a strong, audit-ready starting point.

How is it delivered?

Instantly and digitally. There's no physical shipment — you download the files right after payment and receive a backup link by email.

Do I get updates?

Yes. If we revise this toolkit, you're entitled to the updated version at no extra cost — just contact us with your order details.

What is your refund policy?

These are digital products, so once a toolkit has been downloaded we cannot take it back. If you have not downloaded yet, contact us and we will cancel the order and refund you in full. We also refund in full if the files are damaged, incomplete, or not what the product page described.

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