Last reviewed September 15, 2026
Synapse Forum is built so the sponsor never runs the room.
A partner funds a topic. Synapse chooses and pays the experts, runs the discussion, and fields the survey. The partner receives findings, clips, and reach — never control of what clinicians say, and never the identity of who answered.
This page explains the structure, the laws it is designed around, and what each party does and doesn’t get. It is written for Medical Affairs, Compliance, Legal, Procurement, and the clinicians we invite.
We don’t tell partners this is “legal.” No honest vendor can hand you that, and you couldn’t rely on it if we did. We show you how each element is structured to comply, cite the rule, and give your team a package built to verify in days.
How it’s structured
Every Forum topic runs as two separate activities. They are separate on purpose: each maps to a category regulators already understand, and each has its own contract, data flow, and disclosure rule.
Expert discussion
Independent education, funded by an unrestricted grant
- Partner defines a disease area or therapy class, not a brand message.
- Synapse selects faculty and writes the questions. Partner has no veto.
- Partner review is limited to factual accuracy, adverse events, and its own IP.
- Clinicians are named, paid a fair-market honorarium, and free to disagree.
- Clips and recap are published after the session with the sponsor disclosed.
Why this shape: FDA’s 1997 guidance on industry-supported education treats sponsor control over content or speakers as the line between independent education and promotional labeling.
Blinded survey
Healthcare market research, Synapse as agency of record
- Clinician respondents are recruited and paid by Synapse.
- Partner receives aggregated, de-identified findings only.
- No names, NPIs, emails, IP addresses, or raw rows leave Synapse.
- Adverse events mentioned in responses are forwarded to the partner’s drug-safety team within one business day, anonymized unless the clinician consents.
- Follows BHBIA and EphMRA market-research guidelines.
Why this shape: a payment the manufacturer cannot connect to a named clinician is generally not a reportable indirect transfer of value under Open Payments (42 CFR 403.904) and is disclosed in aggregate under the EFPIA Code.
Lines we don’t cross
These are the five features that turn an independent program into manufacturer promotion or an inducement. We decline scopes that require any of them, and we say so before an order form is signed.
- Clinicians are never required to post.A contractual posting obligation about a therapy is a paid endorsement attributable to the manufacturer (FTC Endorsement Guides; FDA warning letters on influencer content). Sharing is optional and always disclosed.
- Partners never choose or approve speakers or content.Sponsor control over faculty or script is the central FDA independence factor. Review stays limited to accuracy, adverse events, and IP.
- No paid ads push sponsored medical content to the public.Advertising a prescription medicine to the public is prohibited in the EU and UK and in Germany under HWG §10. In the US it would attach full fair-balance obligations. We report reach; we don’t buy it.
- No guaranteed impressions for a named product.Selling guaranteed promotional reach turns honoraria into payment for promotion. We report estimated impressions as analytics, not as a contractual promise.
- Honoraria are never tied to prescribing.Rates are fair-market-value, set in advance from independent benchmarks, and identical regardless of what a clinician says or prescribes — the inverse of the pattern in the OIG’s 2020 speaker-program alert.
The laws we’re built around
In plain language: what each rule is, what it would mean for a program like this, and the specific mechanism we use to stay on the right side of it.
Independent education vs. promotion
FDA Guidance on Industry-Supported Scientific and Educational Activities (1997) · 21 CFR 202.1
If a company controls the content, picks the speakers, or scripts the message, the activity counts as the company’s own advertising and every promotional rule applies.
How we comply: partner sets the disease area only; Synapse selects faculty and questions; review limited to accuracy, adverse events, and IP; funding disclosed on every asset.
Anti-Kickback Statute
42 USC 1320a-7b(b) · OIG Special Fraud Alert: Speaker Programs (Nov 2020)
Paying a prescriber in a way that could induce prescribing is a federal crime. The OIG has flagged programs with sponsor-controlled content, high-prescriber speakers, and above-market fees.
How we comply: fair-market rates set in advance and documented; clinicians selected for expertise, never prescribing volume; annual cap on paid engagements per clinician; legitimate research and education purpose.
Open Payments (Sunshine Act)
42 CFR Part 403, incl. 403.904(i) on indirect payments
Manufacturers must publicly report payments to physicians, including payments routed through a vendor — unless the manufacturer never learns who was paid.
How we comply: blinded survey honoraria stay anonymous to the partner and are generally not reportable; named discussion faculty are reported by the partner, and we supply a report-ready data feed.
FTC Endorsement Guides
16 CFR Part 255 (revised 2023)
Anyone paid in connection with content they share must disclose that clearly and up front. Brands and intermediaries share liability for missing disclosures.
How we comply: sharing is optional; when a clinician shares, our contract requires the exact disclosure text we supply; Synapse monitors and asks for corrections.
Off-label communication
FD&C Act misbranding · FDA SIUU final guidance (Jan 2025)
Discussion of unapproved uses attributable to a manufacturer is misbranding unless it meets narrow, HCP-only conditions.
How we comply: faculty are briefed to keep to approved, evidence-based use; independent clinical opinion that touches unapproved use is flagged as such, never clipped, and never amplified.
State gift and disclosure laws
e.g. Vermont, Massachusetts, Minnesota, Connecticut
Several states restrict or require reporting of manufacturer payments to clinicians beyond the federal rule.
How we comply: honoraria are for bona fide services at fair-market value; state-specific reporting is flagged in the partner’s data feed by clinician state of licensure.
No prescription-medicine advertising to the public
Directive 2001/83/EC Art. 88 · UK Human Medicines Regulations 2012 Part 14 · Germany HWG §10
Promoting a prescription-only medicine to anyone other than healthcare professionals is unlawful across the EU and UK, and UK regulators have treated even a LinkedIn “like” as promotion.
How we comply: in the EU and UK, any content naming a prescription medicine sits behind healthcare-professional verification; public-facing clips are disease-level only.
EFPIA Code of Practice
EFPIA Code (2025 consolidated) · national codes (ABPI, FSA, Farmaindustria, CGR)
Industry members must disclose transfers of value to named clinicians, pay fair-market rates under written contracts, and never pay for mere attendance.
How we comply: named faculty payments are disclosed by the partner; survey honoraria the partner cannot link to a person are disclosed in aggregate; every engagement has a written contract at fair-market value.
ABPI Code and PMCPA rulings (UK)
ABPI Code 2024 · PMCPA social media guidance
The UK self-regulator publishes rulings and has repeatedly found companies in breach for staff or contractors sharing medicine content on social media.
How we comply: no clinician is asked to share; UK content follows the Code’s disease-awareness rules on public surfaces and HCP-only rules elsewhere.
German anti-corruption in healthcare
StGB §§299a, 299b · HWG · MBO-Ä §§30–33
Granting a clinician a benefit as consideration for prescribing or purchasing decisions is a criminal offense for both sides.
How we comply: honoraria are for defined services at documented fair-market value with no link to prescribing; German clinicians receive contracts that satisfy the medical profession’s separation, transparency, equivalence, and documentation principles.
French anti-gift law and Transparence Santé
Code de la santé publique Art. L.1453-3 et seq. · ANSM advertising control
Agreements with French clinicians must be declared to — and above thresholds authorized by — the Ordre, and appear in a public register.
How we comply: French faculty contracts are filed with the Ordre before the session; no promotional material is produced without the required ANSM visa.
GDPR and UK GDPR
Arts. 6, 7, 28, Chapter V · EDPB guidance on anonymization
Clinician data needs a lawful basis, consent for recordings, a processor agreement, and a valid mechanism for any transfer to the US.
How we comply: partners receive anonymized aggregates that are not personal data; any personal data is covered by an Article 28 agreement and Standard Contractual Clauses or the EU-US Data Privacy Framework.
EU AI Act transparency
Regulation (EU) 2024/1689 Art. 50, applicable from 2 Aug 2026
AI-generated or AI-edited audio and video must be labeled, and the deployer is responsible.
How we comply: an editor reviews and signs off every clip; AI-assisted edits are labeled in the EU and marked machine-readably.
Who gets what
The same rules, read as deliverables.
| Item | Partner | Clinician |
|---|---|---|
| Set the disease area or therapy class | Yes | Not applicable |
| Name a brand as the required focus | No | Not applicable |
| Choose or veto faculty | No | Not applicable |
| See content before publication | Accuracy, AE, IP only | Own segments |
| Edit what a clinician said | No | Takedown right in contract |
| Recording, recap, and clips | After session | Own segments |
| Aggregated, de-identified survey findings | Yes | Summary |
| Respondent names, NPIs, emails, raw rows | Never | Not applicable |
| Reach and impression analytics | Estimated, not guaranteed | Not applicable |
| Require a clinician to post | No | Optional, disclosed |
| Disagree with the sponsor on the record | Not applicable | Yes |
| Honorarium | Not applicable | Fair-market, paid by Synapse |
Payments and reporting
Whether a payment is publicly reported depends on one question: can the partner connect it to a named clinician?
What appears where
Disclosure is fixed text, not a judgment call. These are the exact labels on each surface.
Recording intro and recap
Produced independently by Synapse. Funded by an unrestricted grant from [Partner]. The views are the speakers’ own.
Clip overlay
Independently produced · Funded by [Partner] · Speakers’ own views
Clinician’s own post (if they choose to share)
I took part in a discussion funded by an educational grant from [Partner]. Content was produced independently by Synapse.
Survey findings report
Independent market research conducted by Synapse. Commissioned by [Partner]. Respondents are anonymous to the sponsor.
EU and UK surfaces naming a prescription medicine
For healthcare professionals only. Access requires verified professional status.
AI-assisted clips (EU)
Edited with AI tools and reviewed by a Synapse editor.
Questions
Answered plainly. Where the answer is “it depends,” we say what it depends on.
Is this promotional or non-promotional?
Non-promotional by design. The discussion is independent education under an unrestricted grant and the survey is market research. If you want a promotional asset, that is a different product with your normal MLR review and Form FDA 2253 process, and we keep it fully separate.
Do we need MLR review?
The discussion is not your promotional material and is produced outside your control, so it is not a standard MLR piece. We still recommend your medical and compliance teams review for accuracy, adverse events, and off-label safeguards within the firewall scope. We send an MLR-ready package with annotated references so that review is fast.
How is this different from a speaker program the OIG flagged?
The OIG’s November 2020 alert targets programs where the company controls content, picks high-prescriber speakers, pays above market, and uses the room to induce prescribing. We invert every one of those: no content control, disease-level scope, fair-market rates set in advance, expertise-based selection, and anonymized research.
Do we report these payments?
Named discussion faculty: yes, you report those transfers of value, and we supply a data feed with name, NPI, license state, address, amount, and nature. Blinded survey respondents: generally no, because you never learn who they are, which is the condition for the indirect-payment exclusion under 42 CFR 403.904 and for aggregate disclosure under EFPIA.
Can we see content before it goes live, or pick the speakers?
You can flag factual errors, adverse events, and your own IP before publication. You cannot edit opinions, choose faculty, or veto anyone. That limit is what keeps the program independent under FDA’s 1997 guidance. A full editorial preview would turn the content into your labeling.
Who is liable if a clinician makes an off-label or misleading claim?
FDA attributes a paid endorser’s claims to a manufacturer when the manufacturer controls or sponsors the message. Our structure is designed to prevent attribution: the content is independent, not sponsor-controlled, and off-label statements are not clipped or amplified. Clinicians warrant their statements are their own professional opinion, and we indemnify within defined limits. No structure removes all risk; this one is designed to minimize attribution and we document it.
Which budget does this come from, and who should own it?
The discussion belongs with Medical Affairs as independent medical education or an unrestricted grant. The survey belongs with Commercial Insights as market research. Keeping brand marketing at arm’s length from the educational content is one of the core safeguards, so we ask that brand teams are not the content counterpart.
Can clips run on public social media in the EU or UK?
Not if they name a prescription medicine. Those sit behind healthcare-professional verification. Disease-level content that names no product can run more widely, following the MHRA’s disease-awareness guidance and equivalent national rules.
How do you handle adverse events?
Anything that meets the reporting criteria in a discussion or a survey response is forwarded to your drug-safety contact within one business day, anonymized unless the clinician consents to be identified. Our team holds current BHBIA adverse-event training and records are retained for at least five years.
Is survey data compliant for transfer to the US?
What you receive is aggregated and anonymized, so it is not personal data. Any personal data we process on your behalf is covered by an Article 28 processor agreement and a valid transfer mechanism.
Why won’t you just guarantee this is compliant?
Because you cannot rely on a vendor’s legal opinion; you remain independently accountable. What we can do is show you the mechanism behind every element, cite the rule, name who reviewed it, and hand your team a package built to verify quickly. That is a position your own counsel can stand behind.
Is this a speaker bureau?
No. A speaker bureau is where a manufacturer pays you to present its slides about its product. Here the company does not control content or choose speakers, the focus is a disease area or therapy class rather than one brand, and you are not promoting anything.
Will this show up on Open Payments?
If you take the blinded survey, no: the sponsor never learns your identity, and payments it cannot connect to you are not reported. If you are named faculty in the discussion, the sponsor generally must report that payment. We tell you in writing, before you agree, which applies to your role.
Will my institution allow it?
Most academic centers prohibit industry speaker bureaus but permit paid market research and independent education. We give you a short description for your outside-activity form and a letter to your conflict-of-interest office confirming there is no promotional obligation and no required posting. Getting approval is your responsibility; we make it easy to describe accurately.
Can I disagree with the sponsor on the record?
Yes. The sponsor has no editorial veto. Its review is limited to flagging factual errors, adverse events, and its own intellectual property.
Do I have to post anything?
No. Sharing is entirely optional. If you choose to share a clip, we give you the exact disclosure wording to include.
Is my survey answer really anonymous?
Yes. Synapse collects your responses as an independent research agency. The sponsor receives only aggregated, de-identified results with no name, NPI, email, or IP address. The one exception is an adverse-event report, and even then your identity is shared only with your consent.
How was the honorarium set?
From independent physician-compensation benchmarks by specialty and time required, set in advance, and paid at the same rate regardless of what you say or prescribe.
What if I mention an adverse event?
We are required to forward it to the sponsor’s drug-safety team within one business day. We do so without your identity unless you agree to share it for clinical follow-up.
Who owns the recording, and can I take my part down?
Synapse licenses the recording for the program; you receive a license to your own segments and a takedown right for your contribution, on the terms in your agreement.
Am I liable for off-label statements?
The safest course is to keep to approved, evidence-based use. Independent clinical opinion that touches unapproved use is your professional judgment in an educational setting; we ask you to flag it as such, and we do not clip or amplify it.
Will anyone ask me to recommend the sponsor’s product?
No. If anyone ever does, that breaks our own rules. Tell us.
Documents on request
Available to partners under NDA and to clinicians on invitation. Certifications are listed only once held; anything in progress is marked as such.
- Content firewall SOPWhat crosses the wall, who signs off, how requests to edit are logged and declined.
- Fair-market-value methodologyBenchmark sources, tiering, and the annual engagement cap.
- Adverse-event SOPCapture, criteria, one-business-day forwarding, training records.
- Open Payments data-feed specFields, format, and timing for reportable faculty payments.
- Data protection annexArticle 28 terms, transfer mechanism, retention, anonymization method.
- Vendor compliance profileAnti-bribery policy, insurance, security posture, memberships and their status.
- Clinician institutional-approval kitForm language and a letter to the conflict-of-interest office.
- Disclosure and labeling standardExact text for every surface, US and EU/UK variants.
How we describe this
- Structured to comply with a named rule
- Independently produced
- Not a speaker bureau
- Generally not reportable, because…
- Here is the mechanism, and who reviewed it
What we won’t say
- “Fully legal” or “guaranteed compliant”
- “Risk-free”
- “No Sunshine reporting” without the qualifier
- “The sponsor is protected from liability”
- “Cleared with the FDA”