Compliance Playbook for Regulated Industries: Healthcare, Fintech, and SaaS

Compliance isn't one-size-fits-all. You probably already know that, but it's worth saying out loud because the default advice out there — "just get SOC 2" or "start with a risk assessment" — skips the part that actually matters: what your specific industry demands.

A healthtech startup dealing with patient records has wildly different compliance pressures than a fintech company processing card payments. And a B2B SaaS platform selling to enterprises? That's a different game entirely. Same vocabulary, different playbooks.

This guide breaks it down. We'll walk through the regulatory landscape, the common traps teams fall into, and the practical first moves for three of the most compliance-intensive verticals: healthcare, fintech, and SaaS. Whether you're building your program from scratch or trying to figure out what to prioritize next, this is your starting point.

Why Industry Context Matters for Compliance

Let's face it — most compliance advice is generic. "Implement access controls." "Document your policies." "Train your employees." That's all true, but it's like telling someone to "eat healthy" without knowing whether they're a marathon runner or recovering from surgery. Context changes everything.

Here's why industry matters so much:

Regulatory mandates differ by vertical. HIPAA is non-negotiable in healthcare. PCI DSS is mandatory if you touch cardholder data. SOC 2 isn't legally required anywhere, but try selling enterprise SaaS without it.
Your customers set the bar. Hospital systems expect HITRUST. Banks expect SOC 2 and sometimes SOX readiness. Enterprise buyers want ISO 27001. What your market demands shapes your roadmap more than any regulation alone.
Risk profiles vary dramatically. A data breach in healthcare can endanger patients. A breach in fintech can drain bank accounts. A breach in SaaS can expose hundreds of customers at once. The stakes — and the controls you need — shift with your industry.
Auditor expectations change. An auditor reviewing a healthtech company will focus on PHI handling and BAAs. The same auditor at a payments company will zero in on cardholder data environments and network segmentation. Same framework, different lens.

The smart move? Start with your industry's mandatory frameworks, layer on what your customers expect, and build from there. Everything else is noise.

🏥 Healthcare and Healthtech

Healthcare compliance is a world unto itself. The stakes are high — we're talking about patient safety, not just data security — and the regulatory environment reflects that.

The Regulatory Landscape

If you're building anything that touches patient data, here's what you're dealing with:

HIPAA — This is non-negotiable. If you handle Protected Health Information (PHI) in any capacity, HIPAA applies to you. Period. It's not a certification you earn — it's a federal law you must comply with. The Privacy Rule, Security Rule, and Breach Notification Rule all have specific requirements.
HITRUST — Increasingly expected by larger health systems and payers. HITRUST CSF is a certifiable framework that incorporates HIPAA, NIST, ISO, and other standards into a single assessment. It's expensive and time-consuming, but it opens doors that HIPAA alone doesn't.
SOC 2 — More and more healthcare organizations expect their vendors to have SOC 2 reports. It's becoming table stakes alongside HIPAA compliance, especially for SaaS-based healthtech.
State privacy laws — Don't forget these. States like California (CCPA/CPRA), Texas, Washington, and others have their own privacy requirements that layer on top of HIPAA. If you operate nationally, you're juggling multiple state-level mandates.

Common Challenges

Healthcare compliance is uniquely painful for a few reasons:

PHI shows up everywhere. It's in your production database, sure. But it's also in test environments, log files, analytics pipelines, email threads, Slack messages, and that spreadsheet someone downloaded "just to check something." Mapping and controlling PHI is a continuous battle.
Business Associate Agreements (BAAs) are a nightmare to manage. Every vendor that touches PHI needs a BAA. Every subcontractor they use needs one too. Tracking which BAAs are current, which have expired, and which vendors have changed their terms is a full-time job that nobody signed up for.
Clinicians hate security friction. Doctors and nurses are focused on patient care. They don't want to deal with MFA prompts, complex passwords, or restricted access to tools. Balancing usability with security in clinical workflows is one of the hardest design challenges in healthtech.
Breach notification timelines are strict. HIPAA gives you 60 days to notify affected individuals after discovering a breach. That sounds generous until you realize how long it takes to investigate, scope, and communicate internally before you can even start drafting notifications.

Where to Start

If you're a healthtech company figuring out where to begin, here's the practical sequence:

Map your PHI data flows first. Before you write a single policy, understand where PHI enters your system, where it's stored, where it's processed, and where it exits. You can't protect what you can't see.
Conduct a HIPAA risk assessment. This isn't optional — it's explicitly required by the Security Rule. Document your risks, your current controls, and your remediation plans. This is the single most important document in your compliance program.
Build a BAA inventory. List every vendor, contractor, and subprocessor that touches PHI. Track agreement dates, renewal periods, and any terms that affect your security obligations. Automate reminders for renewals.
Implement minimum necessary access. Apply the principle of least privilege aggressively. Users should only access the PHI they need for their specific role. Audit access logs regularly.
Train everyone — and document it. HIPAA requires workforce training, and "everyone watched a video once" doesn't cut it. Role-based training, phishing simulations, and documented completion records are the baseline.

For a deeper dive into HIPAA-specific requirements, check out our HIPAA for healthtech startups guide, explore the HIPAA framework overview, or visit our healthcare industry page for tailored resources.

💳 Fintech and Payments

Fintech compliance is where security meets money — and regulators don't play around when money is involved. The landscape is complex, the stakes are immediate, and the scrutiny is intense.

The Regulatory Landscape

Fintech companies typically face a layered set of requirements:

PCI DSS — If you store, process, or transmit cardholder data, PCI DSS compliance is mandatory. Not "strongly recommended." Mandatory. The card brands (Visa, Mastercard, etc.) enforce it through your acquiring bank, and non-compliance can result in fines, increased transaction fees, or losing the ability to process cards entirely.
SOC 2 — Banks and financial institutions increasingly require SOC 2 Type II reports from their technology vendors. If you're selling to banks, credit unions, or established financial services companies, expect this to come up in every due diligence questionnaire.
SOX readiness — If you're a growth-stage fintech heading toward an IPO or working closely with public companies, Sarbanes-Oxley compliance (specifically IT General Controls) starts becoming relevant. It's never too early to build SOX-friendly processes.
Bank due diligence — Beyond formal certifications, banks have their own vendor risk management programs. These often include lengthy questionnaires, on-site assessments, and ongoing monitoring requirements. Each bank does it slightly differently, which multiplies the effort.
State money transmitter licenses — Depending on your business model, you may need state-level licenses that carry their own compliance requirements, including cybersecurity programs, bonding, and regular examinations.

Common Challenges

Fintech teams run into a specific set of headaches:

Scoping the Cardholder Data Environment (CDE) correctly. In modern cloud-native architectures with microservices, containers, and serverless functions, defining the boundary of your CDE is genuinely difficult. Get it wrong and you'll either over-scope (making compliance unnecessarily expensive) or under-scope (creating real risk and audit findings).
Shared responsibility confusion with payment processors. Using Stripe, Adyen, or another payment processor doesn't magically make you PCI compliant. You still have responsibilities, and the line between your obligations and theirs is frequently misunderstood. SAQ types, shared responsibility matrices, and Attestations of Compliance all need careful review.
Engineering teams resist owning controls. In fintech, many critical controls live in the engineering domain — code reviews, deployment pipelines, access management, encryption implementations. Engineers often see compliance work as overhead that slows them down. Getting engineering buy-in isn't just nice-to-have, it's essential.
Real-time fraud and security monitoring. Financial systems are prime targets. You need robust monitoring, incident response plans, and the ability to detect and respond to threats quickly. Regulators expect it, and attackers will test you.

Where to Start

Here's the practical starting sequence for fintech companies:

Define your cardholder data environment clearly. Draw a network diagram. Identify every system, application, and person that touches cardholder data. Document data flows from ingestion to deletion. This is the foundation of your PCI compliance effort.
Understand your SAQ type. Self-Assessment Questionnaires come in several flavors (A, A-EP, D, etc.) depending on how you handle card data. Picking the wrong one wastes time and creates audit risk. If you're not sure, get help from a Qualified Security Assessor (QSA) early.
Get engineering buy-in from day one. Don't drop compliance requirements on your engineering team after the fact. Involve them in scoping conversations, let them help design controls that fit their workflows, and make compliance part of your engineering culture, not an external imposition.
PCI DSS 4.0.1 compliance is urgent. The transition deadline has passed, and 4.0.1 introduced significant new requirements around authentication, encryption, and security awareness. If you haven't fully transitioned yet, this needs to be your top priority right now.
Build your evidence collection into CI/CD. Automated evidence from your deployment pipeline, access reviews, and change management processes will save you hundreds of hours during audits. The more you can generate evidence programmatically, the less manual scrambling you'll do.

For fintech-specific guidance, explore our PCI DSS for fintech walkthrough, the PCI framework overview, or browse the fintech industry page.

🖥️ B2B SaaS and AI Platforms

If you sell software to other businesses, compliance is the toll you pay to access enterprise customers. It's not a legal requirement in most cases — it's a market requirement. And the market is getting more demanding every year.

The Regulatory Landscape

SaaS and AI companies face a unique mix of voluntary certifications and emerging regulations:

SOC 2 — This is table stakes for selling to enterprise customers. A SOC 2 Type II report is the most commonly requested trust artifact in B2B SaaS. Without one, you'll struggle to close deals with any company that has a security team.
ISO 27001 — Essential for international markets, especially Europe and Asia-Pacific. ISO 27001 certification signals a mature Information Security Management System (ISMS) and is increasingly expected alongside SOC 2.
GDPR — If you process personal data of EU residents (and you almost certainly do if you serve global customers), GDPR compliance is mandatory. The requirements around data processing agreements, data subject rights, and cross-border transfers are non-trivial.
AI governance frameworks — This is the frontier. The EU AI Act is rolling out enforcement, NIST's AI Risk Management Framework is gaining traction in the US, and customers are starting to ask pointed questions about how your AI features handle data, bias, and transparency. If you have AI in your product, governance requirements are no longer hypothetical.

Common Challenges

SaaS companies face their own distinct pain points:

Security questionnaire fatigue. Enterprise customers send security questionnaires as part of procurement. Some companies receive hundreds per year, each with slightly different questions about the same topics. Without a systematic approach, responding to questionnaires can consume entire teams.
Multi-tenancy creates unique control requirements. When multiple customers share infrastructure, you need to prove that Customer A's data can never be accessed by Customer B. Logical separation, access controls, encryption key management, and audit logging all need to account for multi-tenant architecture.
AI features require new governance frameworks. Traditional compliance frameworks weren't designed for machine learning models, training data pipelines, or AI-generated outputs. You need to develop your own governance approach that addresses model documentation, bias testing, data lineage, and transparency — and you need to do it before your customers (or regulators) ask.
Rapid release cycles conflict with change management controls. SaaS teams often deploy multiple times per day. Traditional change management processes (CAB meetings, manual approvals) don't work at that velocity. You need controls that keep up with continuous deployment without creating bottlenecks.

Where to Start

Here's the practical path for SaaS companies:

Get SOC 2 Type II first — it unlocks enterprise deals. Start with the Security Trust Services Criterion (TSC). It covers the essentials and is what most customers ask for. You can add Availability, Confidentiality, and other criteria later as needed.
Build a reusable trust center. Instead of answering the same questions hundreds of times, create a public (or gated) trust center that proactively shares your security posture. Include your SOC 2 report, security whitepaper, penetration test summary, and answers to common questionnaire topics. This alone can cut questionnaire volume significantly.
Start documenting AI governance early. Even if your AI features are simple today, establish the documentation framework now. Record what data your models train on, how you test for bias, what guardrails exist on outputs, and how customers can opt out of AI features. Episki provides structured templates for AI governance documentation that help you build this framework without starting from a blank page.
Automate evidence collection from day one. Screenshots and spreadsheets don't scale. Integrate your evidence collection with your cloud provider, identity provider, CI/CD pipeline, and monitoring tools. When audit season arrives, your evidence should already be there waiting.
Plan for ISO 27001 if international expansion is on the roadmap. SOC 2 and ISO 27001 share significant control overlap, so building toward both simultaneously is efficient. Map the controls once and collect evidence that satisfies both frameworks.

For SaaS-specific resources, read our SOC 2 for SaaS guide, the AI governance and compliance deep dive, the SOC 2 framework overview, or visit the SaaS industry page.

Cross-Industry Themes

Regardless of whether you're in healthcare, fintech, or SaaS, certain compliance truths are universal. Here's what every regulated company needs to get right:

Evidence management is the real bottleneck

The hardest part of compliance isn't understanding the controls — it's proving you've implemented them. Every framework, every audit, every customer questionnaire comes back to the same question: "Show me the evidence."

Companies that build a structured evidence library that scales early will save themselves enormous pain later. Name your artifacts consistently. Assign owners. Set collection cadences. Automate what you can.

Multi-framework overlap is your friend

Here's the good news: frameworks overlap more than you'd think. A well-implemented access control satisfies requirements in SOC 2, ISO 27001, HIPAA, PCI DSS, and GDPR simultaneously. If you're mapping your controls properly, adding a second or third framework shouldn't double or triple your work.

Effective control mapping across frameworks is one of the highest-leverage activities in compliance. Map once, satisfy many. This is where tooling makes a massive difference — manually tracking control overlap across four or five frameworks in spreadsheets is a recipe for missed requirements and duplicated effort. Episki's control mapping features let you see exactly which controls satisfy multiple frameworks, so you can prioritize efforts that deliver the most coverage.

Risk-based prioritization beats checkbox compliance

Not all controls are equally important. A critical encryption control protecting live customer data matters more than a documentation control about your acceptable use policy. Prioritize by actual risk — likelihood and impact — not by control number sequence.

The best compliance programs ask: "What would hurt us most if it failed?" and work backward from there. This approach focuses resources where they matter and produces a genuinely more secure organization, not just a compliant-on-paper one.

Tooling matters more when teams are lean

Enterprise companies can throw bodies at compliance. Startups and growth-stage companies can't. When your compliance team is one or two people (or zero dedicated people), the tools you use determine whether the program succeeds or drowns in manual work.

Look for tools that reduce manual data entry, automate evidence collection, support multiple frameworks, and make it easy to share status across the organization. The right platform pays for itself in time saved within the first audit cycle.

Building Your Industry-Specific Compliance Roadmap

Regardless of your industry, the roadmap follows the same basic shape. The details change, but the structure holds.

Step 1: Identify your mandatory frameworks

What does the law require? What do your customers demand? What do your investors expect? Sort frameworks into three buckets: must-have (legally required or deal-blocking), should-have (expected by most customers), and nice-to-have (competitive differentiator). Start with must-have.

Step 2: Map your data flows

Before you can implement controls, you need to know what you're protecting and where it lives. Map how sensitive data enters your systems, where it's stored, how it's processed, who can access it, and how it leaves. This exercise reveals gaps that no amount of policy-writing can fix.

Step 3: Run a gap analysis

Compare your current state against your target frameworks. For every control, ask: "Do we do this? Can we prove it? Is it documented?" Be honest. A gap analysis that papers over problems just creates audit surprises later.

Step 4: Prioritize by risk and revenue impact

Not every gap is equal. Some gaps create real security risk. Others block revenue (like not having SOC 2 when your biggest prospect requires it). Prioritize gaps that are both high-risk and high-revenue-impact first. This ensures your compliance work directly supports business growth.

Step 5: Build evidence workflows

For every control you implement, define how you'll collect and maintain evidence of that control's operation. Who's responsible? How often is evidence collected? Where is it stored? What's the retention period? This turns compliance from a periodic scramble into a steady, manageable process.

Episki helps with this entire roadmap through pre-built industry templates for healthcare, fintech, and SaaS. Each template comes with controls, evidence requests, and frameworks already mapped — so you're not building from scratch. You start with a structured foundation and customize from there, which cuts weeks off the typical setup process.

Compliance in regulated industries isn't something you figure out once and forget about. It evolves as your company grows, your customer base shifts, and regulations change. But the companies that build a strong, industry-aware foundation early are the ones that scale without compliance becoming a bottleneck.

Pick your industry. Know your frameworks. Map your data. Build your evidence workflows. And if you want a head start, episki includes ready-to-use templates for healthcare, fintech, and SaaS — with controls, evidence requests, and frameworks mapped out of the box. Get started today.