Healthcare AI Governance Services

We help health systems, physician groups, payers, and health tech and revenue cycle vendors find the AI already in use, review the vendors behind it, and govern it under HIPAA, Section 1557, ONC's HTI-1 rule, CMS rules, and state AI laws, with your counsel and clinical leaders making the calls that belong to them.
Book a consultation
Definition

What is healthcare AI governance?

Healthcare AI governance is the set of decisions, controls, and records that determine which AI a health organization uses, with what data, under whose oversight, and how it is monitored. It covers clinical tools such as ambient documentation and decision support, patient-facing chatbots, revenue cycle and prior authorization tools, and AI features vendors add to software you already own. A working program ties each use to HIPAA's business associate and Security Rule requirements, the Section 1557 rule on patient care decision support tools, ONC's HTI-1 criterion, CMS rules, and state AI laws, and gives a named committee authority to approve, restrict, or retire tools.

Services

What do our healthcare AI governance services include?

AI inventory and intake
HIPAA and BAA review
AI risk assessments
Governance program setup
Regulatory mapping
ISO/IEC 42001

Find the AI already in use

We inventory every AI tool and AI feature that touches patients, PHI, or coverage decisions, including shadow AI found through network, identity, and expense data and AI features vendors switched on inside approved software. You get a register with owners, data classes, and risk tiers, plus an intake path for new requests.

Review AI vendors and their BAAs

We review each AI vendor's business associate agreement and product settings against your intended uses: rights to train on your data, retention, subcontractors, data location, breach notice timing, and the features the agreement excludes. You get findings your counsel can take into negotiation and a configuration checklist for IT.

HIPAA risk analysis plus the NIST AI RMF

We extend your Security Rule risk analysis to each AI system's prompts, outputs, logs, and integrations, and assess model risks such as inaccuracy, bias, and drift with the NIST AI Risk Management Framework. You get rated risks with owners and dates, written so OCR, customers, and auditors can follow them.

Committee, policies, and approval workflow

We set up an AI governance committee with clinical, compliance, privacy, security, legal, and operations members, write the charter, AI policy, acceptable use rules, and human review standards, and build approval into the request process teams already use. You get decision rights that say who approves a tool, who can stop one, and when.

Map each AI use to the rules that reach it

We map each AI use to HIPAA, the Section 1557 duty for patient care decision support tools at 45 CFR 92.210, ONC's HTI-1 criterion, CMS Medicare Advantage and prior authorization rules, the FTC Health Breach Notification Rule, and state laws such as California AB 3030 and Texas H.B. 149. Your counsel makes the legal determinations; we supply the facts and the control plan.

ISO/IEC 42001 implementation and internal audit

We implement an ISO/IEC 42001 AI management system for health systems and health tech vendors that want a certifiable program, and we perform the internal audits the standard requires. An accredited certification body performs the certification audit and issues the certificate; we prepare you for it and do not certify.

Our approach

Our approach: inventory, assess, govern, monitor

01

Inventory

We find every AI tool and feature that touches PHI or care decisions, including shadow AI, and record its owner, data, vendor terms, and role in care or coverage.

02

Assess

We review vendors and BAAs, extend the HIPAA risk analysis to each tool, and rate model risks with the NIST AI RMF, so every tool has a documented risk tier and an owner.

03

Govern

We stand up the committee, policies, intake path, and human review rules, and map each use to Section 1557, HTI-1, CMS rules, and state law with your counsel.

04

Monitor

We set up logging, output sampling, and periodic review, and report to leadership on tools by tier, open risks, and incidents, so the program keeps pace as new AI arrives.

contact us

Do you know which AI tools touch your PHI?

Start with a scoped inventory and BAA review. We will show you what is in use, which vendors lack the right agreement, and which uses need clinical review first.

Our Advantage

Why BD Emerson for healthcare AI governance

HIPAA and security depth

Our HIPAA practice runs Security Rule risk analyses and compliance programs, and our security team tests the systems AI depends on. Healthcare AI governance builds on that work instead of starting a parallel program.

AI governance standards practice

We implement ISO/IEC 42001 management systems, perform internal audits, and assess AI risk with the NIST AI RMF. We prepare you for certification, and an accredited certification body issues the certificate.

Vendor-neutral advice

We do not resell AI software or licenses and take no resale margin, so our recommendation on which tool to approve, restrict, or replace rests on your risk, your data, and your contracts.

How We Work

Controls a health system AI program needs

The controls we build into a healthcare AI program, each tied to a HIPAA, Section 1557, or state law requirement and to the NIST AI RMF.
Reviews

What our customers say

Great consulting firms for scaling security, compliance, and appsec.

Outstanding partner in Technical and Cyber Due Diligence

Appsec maturity and application hardening.

BD Emerson helped us simplfiy our compliance management.

BD Emerson did such a phenomenal job. What started as privacy support quickly became a full partnership across compliance, engineering, and even business operations. They’re embedded with our team. They understand our product. They move fast. They’re simply invaluable.

Adam Ben Jacobs

CTO @ OneStep GPS

Great consulting firms for scaling security, compliance, and appsec.

Outstanding partner in Technical and Cyber Due Diligence

Appsec maturity and application hardening.

BD Emerson helped us simplfiy our compliance management.

BD Emerson did such a phenomenal job. What started as privacy support quickly became a full partnership across compliance, engineering, and even business operations. They’re embedded with our team. They understand our product. They move fast. They’re simply invaluable.

Adam Ben Jacobs

CTO @ OneStep GPS

We had a hard time finding the right company to partner with in support of our compliance journey. Some vendors sell the idea that they do the work, but then you end up doing everything. The ambiguity is what killed our last project. BD Emerson’s team has such great technical knowledge and understands the standard so well that they made us comfortable with moving fast. This has led to us closing major enterprise customers that were previously out of reach because of security and compliance.

Tom Watkins

CEO @ AMI AssetTrack

Lead an enterprise initiative to overhaul the organization's technology stack from ecommerce, corporate tech, and corporate security.

Supported ISO 42001 exercise and served as internal auditor.

Rubrik's privacy and compliance team began with the backbone of BD Emerson. BD Emerson supported building out the privacy program, GRC (ISO 27001, SOC 2, CMMC, FedRAMP), and the appsec function.

We needed a partner who could move quickly, without sacrificing precision. BD Emerson brought the expertise, structure, and speed we were looking for. Their team became an extension of ours, embedding themselves across the organization, guiding us step by step, and giving us confidence in areas we hadn’t tackled before. The internal audit they conducted was so detailed that even the external auditors called it out. Achieving ISO 27001 with zero nonconformities says everything you need to know about the quality of the partnership.

Walid Souilem

CTO @ FGI Worldwide

We had a hard time finding the right company to partner with in support of our compliance journey. Some vendors sell the idea that they do the work, but then you end up doing everything. The ambiguity is what killed our last project. BD Emerson’s team has such great technical knowledge and understands the standard so well that they made us comfortable with moving fast. This has led to us closing major enterprise customers that were previously out of reach because of security and compliance.

Tom Watkins

CEO @ AMI AssetTrack

Lead an enterprise initiative to overhaul the organization's technology stack from ecommerce, corporate tech, and corporate security.

Supported ISO 42001 exercise and served as internal auditor.

Rubrik's privacy and compliance team began with the backbone of BD Emerson. BD Emerson supported building out the privacy program, GRC (ISO 27001, SOC 2, CMMC, FedRAMP), and the appsec function.

We needed a partner who could move quickly, without sacrificing precision. BD Emerson brought the expertise, structure, and speed we were looking for. Their team became an extension of ours, embedding themselves across the organization, guiding us step by step, and giving us confidence in areas we hadn’t tackled before. The internal audit they conducted was so detailed that even the external auditors called it out. Achieving ISO 27001 with zero nonconformities says everything you need to know about the quality of the partnership.

Walid Souilem

CTO @ FGI Worldwide

BD Emerson didn’t just help us meet our compliance goals; they integrated security and privacy into the core of our operations. I highly recommend BD Emerson to anyone seeking SOC 2 or GDPR compliance, or simply looking to enhance their security team and boost customer trust in their product and services. Their dedication and expertise have been invaluable to our success.

Padraig Reilly

CEO, Boxcore

BD Emerson understood our business requirements and worked side-by-side with us. The policies and controls we developed together not only meet compliance standards but improve how we operate day to day.

Matt Meierdierks

IT Manager, Lincoln Industries

From day one, BD Emerson brought urgency, clarity, and a sharp understanding of what truly matters to our business — earning and keeping customer trust. They went beyond helping us meet compliance requirements; they helped build a foundation for secure, scalable growth. That kind of partnership is rare.

Jason Marker

CEO @ LifeLenz

BD Emerson didn’t just help us pass an audit—they helped us build a sustainable culture of security.

Alexey Indeev

CTO Spare

BD Emerson was essential in helping our company navigate the daunting process of leveling up our security infrastructure. BD Emerson’s impressive expertise and confidence throughout the process helped our team exceed HIPAA and SOC 2 Type 1 standards quickly, distilling what can be an overwhelming process into a streamlined, organized effort. From day one they began adding value and getting us on course. With their help we delivered on a massive security overhaul with both extreme efficiency and thorough attention to details. Because of BD Emerson’s support, we’ve increased our clients’ trust in Titan Intake and the life-changing work it accomplishes for those seeking specialist referrals.

Patrick Bruce

CEO, Titan Intake

BD Emerson didn’t just help us meet our compliance goals; they integrated security and privacy into the core of our operations. I highly recommend BD Emerson to anyone seeking SOC 2 or GDPR compliance, or simply looking to enhance their security team and boost customer trust in their product and services. Their dedication and expertise have been invaluable to our success.

Padraig Reilly

CEO, Boxcore

BD Emerson understood our business requirements and worked side-by-side with us. The policies and controls we developed together not only meet compliance standards but improve how we operate day to day.

Matt Meierdierks

IT Manager, Lincoln Industries

From day one, BD Emerson brought urgency, clarity, and a sharp understanding of what truly matters to our business — earning and keeping customer trust. They went beyond helping us meet compliance requirements; they helped build a foundation for secure, scalable growth. That kind of partnership is rare.

Jason Marker

CEO @ LifeLenz

BD Emerson didn’t just help us pass an audit—they helped us build a sustainable culture of security.

Alexey Indeev

CTO Spare

BD Emerson was essential in helping our company navigate the daunting process of leveling up our security infrastructure. BD Emerson’s impressive expertise and confidence throughout the process helped our team exceed HIPAA and SOC 2 Type 1 standards quickly, distilling what can be an overwhelming process into a streamlined, organized effort. From day one they began adding value and getting us on course. With their help we delivered on a massive security overhaul with both extreme efficiency and thorough attention to details. Because of BD Emerson’s support, we’ve increased our clients’ trust in Titan Intake and the life-changing work it accomplishes for those seeking specialist referrals.

Patrick Bruce

CEO, Titan Intake

Certificates

Our accreditations

Our practitioners hold security, privacy, cloud, and AI governance certifications, and the people who earned them do the work on your engagement.

Guides

Guides on healthcare AI governance

Practical guides on HIPAA, AI vendors, and the rules that govern AI in health systems, payers, and health tech companies.

FAQ

Frequently asked questions

Does HIPAA cover AI tools?

Do AI vendors need to sign a BAA?

What does Section 1557 require for AI tools?

Who belongs on a healthcare AI governance committee?

Is ISO 42001 certification required?

How long does a healthcare AI governance program take?

How do you work with our counsel and clinical leaders?

What drives the cost of a healthcare AI governance program?

Blog

Related Articles

Insights on strategy, transactions, technology, security, and compliance from BD Emerson's practitioners