Hiring the wrong content marketing agency is a headache for most companies. For a regulated brand, it can be a genuine legal exposure. A healthcare system or a financial services firm can't treat marketing the way a typical B2B company does, because the same blog post, testimonial, or landing page that's perfectly fine for most industries can trigger real regulatory risk in yours.
This isn't legal advice, and your compliance and legal teams should always have the final say. But the marketing side of that conversation matters too, and most agency evaluation checklists never touch it. Regulated industry marketing, healthcare marketing and financial marketing especially, needs a layer of scrutiny that generic enterprise marketing services aren't built to handle. If you're a healthcare or financial brand leader evaluating content marketing agencies, here are ten compliance-related questions worth asking before you sign anything.
1. Will they sign a Business Associate Agreement, and do they understand why it matters?
If a marketing agency will ever touch protected health information, even indirectly through appointment forms, patient testimonials, or intake funnels, HIPAA requires a signed Business Associate Agreement between you and that agency. HHS's own guidance on business associates lays out exactly when that obligation kicks in. An agency that hesitates on this question, or doesn't seem to know what a BAA is, isn't ready to work with a healthcare brand yet, no matter how strong their portfolio looks.
2. Do they actually understand the SEC's marketing rule for financial services?
If you're a registered investment adviser, the SEC's marketing rule governs how you can use testimonials, endorsements, and performance advertising, and it replaced the old advertising rule with a more detailed, more heavily enforced framework. The SEC's own compliance guide for investment adviser marketing is worth reading yourself before you ask an agency about it, so you can tell the difference between an agency that genuinely understands the rule and one that's reciting buzzwords back to you.
3. Is compliance review built into their content workflow, or bolted on at the end?
An agency that treats legal review as a final rubber-stamp step, after the content is written, designed, and basically locked, is setting you up for rework at best and a compliance miss at worst. Ask to see where compliance sign-off sits in their actual production process. It should be a defined stage with real time built in, not an afterthought squeezed in before a deadline.
4. Can they explain FTC substantiation standards for health and wellness claims?
Any health-related claim in your marketing, not just from a pharmaceutical company, but from a hospital system, a clinic, or a wellness brand, needs to be backed by what the FTC calls competent and reliable scientific evidence. The FTC's Health Products Compliance Guidance spells out what that standard actually requires. An agency writing health content without a clear substantiation process is writing claims your legal team will eventually have to defend.
5. Do they have a real position on tracking pixels and PHI exposure?
This is one of the more fast-moving compliance areas in healthcare marketing. HHS has guidance on how tracking technologies like analytics and ad pixels interact with HIPAA, and that guidance has already been through real legal turbulence: a federal court vacated part of it in 2024, specifically the piece requiring providers to treat any IP address visiting a health-related page as protected information. The core expectation on authenticated patient portals still stands. An agency setting up your marketing analytics needs to know the difference, not just install a pixel and move on.
6. Do they follow FTC rules on testimonials and endorsements?
The FTC's updated Endorsement Guides require clear disclosure of material connections and prohibit implying results are typical when they aren't. For a healthcare or financial brand, testimonials carry extra weight and extra risk, a patient or client success story that reads as a guaranteed outcome is exactly the kind of thing that draws regulatory attention. Ask how the agency handles disclosure language and typicality disclaimers before you let them build a testimonials program.
7. Do they have a documented recordkeeping process for what they publish?
If you're in financial services, FINRA Rule 2210 requires principal approval and retention of communications with the public, and that obligation doesn't disappear just because an outside agency wrote the piece. Ask how they document approvals, track versions, and retain records in a form your compliance team can actually produce if asked. "We'll email it to you" isn't a recordkeeping process.
8. Is their content built to meet accessibility standards?
Regulated industries carry outsized accessibility exposure, in part because healthcare and financial services are considered essential public-facing services. The Department of Justice's own guidance confirms that businesses open to the public are expected to make their web content accessible, and WCAG standards are the commonly accepted technical benchmark for what that means in practice. Ask whether accessibility is part of the agency's actual build process, including web development, not something addressed after a complaint.
9. Can they show a real claims-substantiation and citation process?
Beyond the specific health and financial claim rules above, regulated brands need agencies that source and verify factual claims as a matter of habit, not just when a specific regulation forces the issue. Ask to see an example of how they fact-check and cite a claim before it goes live. An agency that treats persuasive copy and accurate copy as the same thing is a liability in any regulated vertical.
10. Do they have a plan for when a regulator or a complaint flags published content?
Eventually, something gets flagged, a regulator inquiry, a patient or client complaint, an internal legal review that catches something after the fact. Ask what happens next: how fast can content come down or get corrected, who owns that response, and how do they document what changed and why. An agency without a clear answer here is telling you they've never actually had to handle it, which is exactly the wrong agency for a regulated brand to find that out with.
Why this list looks different from a typical agency checklist
Most agency evaluation guides focus on strategy, creative quality, and reporting, and those things still matter, whether you're comparing general B2B marketing agencies or ones that specialize in regulated industries. We've written about what to look for in a B2B digital marketing agency and what to fix internally before you even start evaluating anyone, and those fundamentals apply here too. But for a healthcare or financial brand, compliance readiness has to sit alongside strategy from day one, not get layered on after you've already picked a partner.
If you're evaluating content marketing agencies for a regulated brand and want to talk through how compliance actually fits into a content program, talk to our team. We'll walk through what we'd build, and where your legal and compliance teams need to stay in the loop no matter who you hire.
