Fast-Track · Weeks, Not Months

HIPAA Compliance USA

HIPAA Security & Privacy Rule Compliance for US Healthcare & Business Associates

Praxis-Q delivers full HIPAA compliance services for US healthcare organizations, covered entities, and their global business associates. Our team delivers risk analysis, policy development, BAA drafting, and HIPAA audit readiness - aligned to the HHS Office for Civil Rights (OCR) audit protocol.

At a Glance

Rules

Security+Privacy

HITECH

Included

Delivery

Weeks

BAA

Included

HIPAA compliance today still runs on the 2013 Omnibus Rule's Security Rule structure - a distinction between 'required' and 'addressable' implementation specifications that gives covered entities and business associates real flexibility in how they meet each safeguard - but that's set to change substantially: HHS's Office for Civil Rights published a Notice of Proposed Rulemaking in the Federal Register on January 6, 2025 that would eliminate the required/addressable distinction entirely and mandate specific controls (multi-factor authentication, encryption at rest and in transit with narrow exceptions, network segmentation, a current asset inventory and network map, regular vulnerability scanning and annual penetration testing) across the board. As of late 2026, industry reporting indicates the final rule has been delayed and may not land until 2027, but Praxis-Q builds new clients to the proposed rule's stricter posture now rather than the minimum the current rule technically requires, since that's the direction every signal points and retrofitting later costs more than building right the first time.
Who does the work: engagements are led by practitioners holding CISA (ISACA), CEH (EC-Council), eJPT (INE) and ISO/IEC 27001 Lead Auditor credentials. The principal consultant's CISA is verifiable on Credly.
Who you are working with: Praxis-Q is the compliance and cybersecurity practice of Techtweek Infotech LLC, a Wyoming-registered company, and of PraxisQ Consulting LLP (India). SOC engagements are contracted through the LLC; other services through the LLP (see Terms). Delivery is remote-first from our India practice; email is answered within 24 hours and calls are by appointment. Book a US-hours call or reach the team on +1 917-508-5334.

HIPAA USA

HIPAA Compliance USA

HIPAA Security & Privacy Rule Compliance for US Healthcare & Business Associates

The Problem

One mishandled patient record can trigger OCR penalties and destroy patient trust. Most healthcare orgs assume they are compliant until an audit proves otherwise.

What We Do

  • ePHI Inventory
  • Risk Analysis
  • Policies
  • BAA
  • Report

What You Get

  • HIPAA Security Rule full compliance
  • HIPAA Privacy Rule assessment
  • HITECH Act and Breach Notification
  • HHS OCR audit protocol aligned
  • ePHI risk analysis and risk management
  • Business Associate Agreement (BAA) drafting
  • Workforce HIPAA training materials
  • Incident response and breach notification procedures

Why weeks, not months

AI-assisted evidence review, one client portal

Every HIPAA USA engagement runs on the Praxis-Q compliance platform. You upload evidence per control, AI scores it against the requirement, and your auditor reviews in the same workflow — from scoping through to the issued, publicly verifiable certificate.

AI evidence scoring

Every upload is scored against the control before an auditor sees it — gaps surface in minutes, not at the review meeting.

One client portal

Scoping, evidence, auditor queries and status live in one place. No email chains, no spreadsheet trackers.

Auditor sign-off

Praxis-Q auditors review inside the same workflow, so review rounds shrink and the certificate issues sooner.

The Security Rule, Privacy Rule and Business Associate Agreements Today

The current, binding Security Rule requires covered entities and business associates to implement administrative, physical and technical safeguards, with each implementation specification classified as either 'required' (must be implemented as specified) or 'addressable' (must be assessed, and either implemented, implemented with a reasonable alternative, or documented as not applicable if genuinely not reasonable given the entity's risk analysis). The Privacy Rule separately governs how protected health information can be used and disclosed. Any vendor handling PHI on behalf of a covered entity needs a signed Business Associate Agreement in place before any PHI changes hands - Praxis-Q drafts and reviews BAAs as a standard part of every HIPAA engagement, since a missing or inadequate BAA is one of the most common and most easily avoided compliance gaps we find.

The Proposed 2025 Security Rule Overhaul

The NPRM published January 6, 2025 would be the most significant change to the Security Rule since 2013, eliminating the required/addressable distinction so that virtually every implementation specification becomes mandatory, and adding explicit new requirements: multi-factor authentication throughout the environment, encryption of ePHI at rest and in transit (with only narrowly defined exceptions), a current technology asset inventory and network map updated at least every twelve months, vulnerability scanning at least every six months, annual penetration testing, defined patch management timelines, and written verification from business associates that required safeguards are actually in place rather than just attested to in a contract clause. As of late 2026, reporting from multiple industry sources indicates finalization has been delayed, with some estimates now pointing to 2027 for a final rule - Praxis-Q treats the direction of the proposal as settled even while the exact effective date remains genuinely uncertain.

Business Associate Agreements and Downstream Subcontractors

A BAA obligation doesn't stop at your direct vendor relationship - if your business associate uses subcontractors that also touch PHI (a cloud hosting provider, a backup service, an analytics tool), those subcontractors need their own BAAs flowing down the chain, and the proposed rule would add a requirement for business associates to provide written verification that their own safeguards are actually implemented, not just contractually promised. Praxis-Q maps the full data flow, not just the direct vendor list, to catch subcontractor BAA gaps that a surface-level review misses.

Overlap With SOC 2 for Health-Tech Vendors

Health-tech vendors selling into healthcare customers frequently need both HIPAA compliance (for the BAA relationship and to satisfy the covered entity's own compliance obligations) and a SOC 2 report (because that's what the broader SaaS buyer market expects regardless of industry). The control overlap is substantial - access controls, encryption, incident response, audit logging - which is why Praxis-Q scopes HIPAA and SOC 2 engagements together for health-tech clients, building evidence once and mapping it to both requirements rather than running duplicate, disconnected programmes.

Engagement Timeline

A HIPAA risk assessment against the current Security Rule typically takes one to two weeks. Policy development, BAA drafting/review, and control remediation follow depending on the gaps identified - organisations already running a reasonably mature security programme close gaps faster than those building HIPAA compliance from a standing start. Praxis-Q builds new engagements against the proposed rule's stricter requirements from day one so clients aren't rebuilding their programme again whenever the final rule does land.

Frequently Asked Questions

Do our offshore vendors and subcontractors need HIPAA compliance?
Yes. Any organization that creates, receives, maintains or transmits ePHI on your behalf - wherever it is located - is a Business Associate under 45 CFR 160.103 and must comply with the Security Rule and sign a BAA. That includes offshore software, BPO and IT service providers; a covered entity remains responsible for vetting them.
What is the penalty for HIPAA non-compliance?
HHS OCR fines range from $100 to $50,000 per violation, up to $1.9 million per category per year. Willful neglect can result in criminal charges. Most enforcement actions follow breach reports.
Does Praxis-Q provide HIPAA BAA drafting?
Yes. BAA drafting and review is included in all HIPAA compliance engagements. We also review third-party BAAs provided by US clients before you sign.
What does a HIPAA compliance consultant deliver?
A Security Rule risk assessment (45 CFR 164.308(a)(1)) that OCR will accept as the enterprise-wide, documented analysis it asks for in every investigation; a Privacy Rule audit of notices, minimum-necessary practice, patient-rights handling and disclosures; Business Associate Agreements; policies mapped to each administrative, physical and technical safeguard; workforce training records; and a remediation plan with owners and dates. Praxis-Q delivers the assessment and the evidence set, so a breach investigation or a customer security review starts from a complete file.
Is HIPAA the same thing as HITECH?
No - HITECH (the Health Information Technology for Economic and Clinical Health Act, 2009) amended and strengthened HIPAA, notably extending direct liability to business associates and introducing the Breach Notification Rule, but it's not a separate compliance framework you address independently. HIPAA compliance work today already incorporates the HITECH amendments.
Do we need a signed BAA with every vendor?
Yes, with every vendor or subcontractor that creates, receives, maintains or transmits protected health information on your behalf - this includes cloud hosting providers, backup services, and any subcontractor further down the chain that also touches PHI. A missing BAA is one of the most common findings in a Praxis-Q gap assessment.
Is the new HIPAA Security Rule final yet?
Not as of late 2026 - the NPRM was published in January 2025, and industry reporting indicates the final rule has been delayed, with some estimates now pointing to 2027. Praxis-Q recommends building to the proposed rule's requirements now regardless, since the direction is clear even if the exact effective date isn't.
What happens if OCR audits us and we have gaps?
HHS's Office for Civil Rights can require a corrective action plan, and depending on the nature and cause of the violation (especially where willful neglect is found), civil monetary penalties can apply. A documented, good-faith risk analysis and remediation plan - even one not yet fully complete - materially changes how OCR treats an organisation compared to one with no risk analysis at all.
Does a SOC 2 report cover our HIPAA obligations?
Not directly - SOC 2 doesn't address the BAA requirement, the Privacy Rule, or HIPAA's specific breach notification timelines, and there's no formal mapping between the two. There's real control overlap (access management, encryption, incident response) that Praxis-Q reuses across both engagements, but a SOC 2 report on its own isn't a substitute for a HIPAA risk assessment or a signed BAA.
Do we need MFA and encryption now, or only once the new rule is final?
Under the current rule, MFA and encryption are largely 'addressable' specifications that can be met with a documented reasonable alternative if genuinely justified by your risk analysis - but the proposed rule would make both effectively mandatory with narrow exceptions. Praxis-Q recommends implementing both now rather than relying on the addressable flexibility, since it's both good security practice and the direction the rule is unambiguously heading.

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