Online video advertising for digital health products in the United States

Medical purpose determines the software review route

Regulator guidance

Medical-purpose software can require a device assessment. Separate regulated functions from general lifestyle functions, then check the exact claims and version against the applicable regulatory position. Do not present every health app as FDA approved.

Sources: Software as a Medical Device (SaMD); General Controls for Medical Devices

Match the evidence to the precise advertised benefit

Regulator guidance

Applies when: The claim falls within FTC health-advertising oversight; FDA product-specific requirements also need review.

FTC guidance generally expects randomised controlled human clinical testing for health-benefit claims, with design and quality appropriate to the claim and the scientific field. Animal studies or consumer anecdotes alone do not establish human benefits.

Assess the actual formulation, dose, population and outcome. An ingredient study or a clinically tested claim must not imply a proven finished-product effect that the evidence does not support.

Sources: FTC Health Products Compliance Guidance · FTC Health Products Compliance Guidance, substantiation and amount/type of evidence

Review implied claims as well as literal wording

Regulator guidance

FTC guidance assesses the overall impression of health advertising. Hold appropriate scientific evidence before publication; an honest testimonial does not substitute for evidence of the advertised result. Treat imagery and omitted qualifications as part of that assessment.

Sources: FTC Health Products Compliance Guidance

Disclose a material commercial connection clearly

Regulator guidance

Make payment, free benefits and other material connections clear with the endorsement. Disclosures should be easy to notice and understand, including within videos and repeated where needed in live streams. A profile disclosure or platform tool alone may be insufficient.

Sources: Disclosures 101 for Social Media Influencers

Washington health data may be regulated outside HIPAA

Regulator guidance

Applies when: Processing within the scope of Washington’s My Health My Data Act.

Where Washington’s My Health My Data Act applies, collection generally needs purpose-specific consent unless necessary for a requested product or service; sharing requires a distinct consent unless the necessary-service exception applies. Review applicability and exemptions by data and activity, rather than assuming HIPAA status clears advertising tracking. Regulated entities must prominently link a separate consumer health data privacy policy from the homepage.

Sources: Washington consumer-health-data collection and sharing; My Health My Data Act — scope and FAQ

Approve the final audiovisual edit

Editorial recommendation

Review speech, captions, demonstrations, overlay visibility and playback speed. Recheck short edits and silent versions against applicable product warning and disclosure requirements.

State expected results instead of relying on a generic disclaimer

Regulator guidance

FTC guidance says an honest endorsement can still mislead. When a testimonial communicates exceptional results, a generic results-not-typical disclaimer does not cure the impression; disclose the results consumers can generally expect and substantiate the underlying claim.

Sources: FTC Health Products Compliance Guidance · FTC Health Products Compliance Guidance, consumer testimonials and expert endorsements

Digital Health Products: prepare the review

Editorial recommendation

Classify each software function separately: lifestyle, medical software or delivery of care. Link accuracy and clinical outcome claims to the advertised software version and population. Review tracking and marketing data flows separately from permission to provide care.

Keep a traceable campaign decision

Editorial recommendation

Keep one review record linking the offer, local market status, claim evidence, exact creative, media settings and any regulatory or professional clearance. Record who checked each condition. Reopen the review when the offer, claim, source rule or execution changes.