Question 1

Are we a Business Associate or a Covered Entity?

Accepted Answer

MedTech and digital health companies are almost always Business Associates - you handle PHI on behalf of a hospital, clinic, or other covered entity. A small number of direct-to-patient products operate as Covered Entities. We confirm your status in week 1; the program covers either.

Question 2

How is this different from your HIPAA penetration testing service?

Accepted Answer

HIPAA penetration testing is a technical assessment of your systems against Security Rule technical safeguards. This page is the full program - risk analysis, policies, BAAs, training, breach response, and evidence - which is what hospitals, OCR, and cyber-insurance underwriters actually evaluate. Most teams need both; the pen test produces evidence for the program.

Question 3

Why does our risk analysis have to cover the device, not just the cloud?

Accepted Answer

OCR expects the Security Risk Analysis to cover all systems that create, receive, maintain, or transmit ePHI. For a connected medical device that includes the device itself, its wireless interfaces, the update pipeline, and the cloud back-end. Scoping only the cloud is the most common mistake we see and the one OCR investigators flag first.

Question 4

Do you sign BAAs on our behalf with our customers?

Accepted Answer

No - the BAA must be signed between you (the Business Associate) and your customer (the Covered Entity or upstream BA). We provide a defensible BAA template, review redlines from hospital legal teams, and track all signed BAAs in your evidence vault. We also help you sign BAAs with your sub-processors (cloud providers, analytics vendors, support tools).

Question 5

How much overlap is there with SOC 2 and HITRUST?

Accepted Answer

Significant. The HIPAA Security Rule, SOC 2 (Security + Availability + Confidentiality), and HITRUST e1/i1 share roughly 60-75% of their controls. We crosswalk every HIPAA standard to SOC 2 and HITRUST in week 1 so you build the controls once and produce evidence for all three.

Question 6

What if a breach actually happens?

Accepted Answer

The 60-day breach notification clock starts from discovery, not investigation completion. Our breach response runbook gives you a decision tree, OCR notification templates, individual notification language, and a draft statement for your customers and the media. We also coach you through the actual response if you're an active client when a breach occurs.

Question 7

What workforce training does HIPAA actually require?

Accepted Answer

The Security Rule (164.308(a)(5)) requires a security awareness and training program for all workforce members - not just engineers - covering password management, malware protection, login monitoring, and security incident reporting. The Privacy Rule (164.530(b)) requires policies-and-procedures training within a reasonable time of hire and after material changes. We deliver a 30-minute baseline training, a developer-focused secure-coding module, an annual refresh, and the attendance-tracking evidence OCR will ask for. Training has to be documented per workforce member - missing logs is the second-most-common OCR finding after missing risk analysis.

Question 8

How do we manage HIPAA obligations with our cloud and analytics sub-processors?

Accepted Answer

Every sub-processor that touches ePHI - cloud (AWS/Azure/GCP), observability (Datadog/Sentry), analytics (Mixpanel/Amplitude), customer support (Zendesk), and AI APIs (OpenAI/Anthropic enterprise) - needs a signed BAA before production data flows. We inventory your sub-processors, classify which ones touch ePHI, secure BAAs from each (or recommend a HIPAA-eligible alternative), and store everything in the evidence vault with renewal alerts. We also help you flow down BAA obligations contractually so your sub-processors' sub-processors are covered.

Question 9

Will this satisfy our cyber-insurance and customer security questionnaire requirements?

Accepted Answer

Yes - that's a primary use case. Cyber insurers and hospital security teams ask the same questions: do you have a current Security Risk Analysis, a designated Security Officer, BAAs with sub-processors, an incident response plan, encryption of ePHI in transit and at rest, MFA on production systems, and quarterly access reviews. The HIPAA program produces the artifacts that answer all of these in one pass. We also deliver pre-completed responses for the SIG, CAIQ, and HECVAT questionnaires so your sales team doesn't bottleneck on security review.

Question 10

What happens if OCR opens an investigation - how do we use what you delivered?

Accepted Answer

OCR investigations open with a data request: produce your Security Risk Analysis, risk management plan, policies, training records, BAAs, and breach response history. Teams that don't have these on hand spend 60-90 days assembling them under deadline pressure - a common path to a settlement. With the program in place, you respond within the initial 30-day window with documented, dated evidence. We also coach you through the response itself if you're an active client when an investigation opens, including drafting the OCR response letter and preparing leadership for any required interviews.

HIPAA for MedTech. A program, not a binder.

Why generic HIPAA programs fail MedTech

Risk analysis scoped wrong

Policies no one operates

BAAs as an afterthought

Safeguards we build and operate

Administrative safeguards

Technical safeguards

Physical safeguards

Privacy + Breach

How the HIPAA program runs

1. Scoping & risk analysis

2. Policies & safeguards build

3. BAAs, training, breach runbook

4. Evidence vault & ongoing program

Reviewer-ready deliverables in one engagement

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HIPAA Compliance Program for MedTech - scoped, fixed-fee, FDA-ready.