Digital innovations in pharmaceuticals have moved from marketing websites to software that patients use alongside their medicines: dose trackers, injection guides, symptom diaries, connected inhalers and apps that help patients stay on therapy. Because this software comes from the drug maker and relates to a prescription product, it sits under rules that general health apps do not face.
This guide is for digital, regulatory and product leaders at drug and biologics companies, and for the teams building their software. It covers the kinds of drug-adjacent software companies build, what FDA's guidance on prescription drug use-related software means for app content, when a companion app becomes a medical device, which privacy rules apply, and how to build and release software whose screens may count as drug labeling.
What are digital innovations in pharmaceuticals?
Building drug companion or therapy software?
Agnotic builds digital therapeutics and drug companion software with regulatory review, evidence capture and privacy controls built in.
Digital innovations in pharmaceuticals are software products that drug makers offer alongside their medicines, such as companion apps, dosing aids, connected device software and adherence programs. When this software is disseminated by or for a sponsor for use with a prescription drug, FDA's prescription drug use-related software guidance governs how its outputs are treated.
These products aim to help patients use a medicine correctly and consistently, give clinicians better information about how treatment is going, and in some cases deliver part of the therapy itself. They also generate data that can support evidence about real-world use, if it is collected with the right consent.
Which kinds of drug-adjacent software are companies building?
Drug makers are building software that supports administration, tracks use and symptoms, connects to delivery devices, and supports patients and clinicians across a course of treatment. The type of software affects which rules apply and how much regulatory work it needs.
- Dosing and administration aids: Step-by-step guides for injections, inhalers or complex regimens.
- Trackers and diaries: Logs of doses, symptoms and side effects that patients can share with clinicians.
- Connected device software: Apps that read data from smart injectors, inhalers or pill packaging.
- Adherence support: Reminders, refill prompts and education tied to a specific therapy.
- Clinician tools: Dashboards showing patient-reported data or device readings for prescribers.
- Digital therapeutics: Software that delivers a therapeutic intervention, sometimes paired with a drug.
What is FDA's guidance on prescription drug use-related software?
FDA's guidance, Regulatory Considerations for Prescription Drug Use-Related Software, describes how the agency applies its drug labeling authorities to certain software outputs disseminated by or on behalf of a drug sponsor for use with a prescription drug or a drug-led combination product. FDA issued the final guidance in October 2026, finalizing a draft from September 19, 2023.
The guidance applies to products where the Center for Drug Evaluation and Research or the Center for Biologics Evaluation and Research is the lead center. Its core idea is that what the software shows to patients or clinicians is information about the drug, so the rules for drug labeling, rather than only general software rules, shape what the app may say.
Teams that built products under the draft should compare their approach with the final text, since final guidance can change definitions, examples and submission expectations. The FDA page linked in the sources is the place to start.
How does FDA treat what a companion app shows users?
In the 2023 draft, FDA described end-user output as the material software presents to the user, such as screens, sounds or reports, and said this output is labeling for the drug. Depending on the evidence behind it, output could be described in the drug's FDA-required labeling or treated as promotional labeling.
For product teams, the practical effect is that app content becomes part of the drug's regulated communication. Claims on a screen need support, fair balance and review just like a brochure. Promotional labeling is generally submitted to FDA at first use with Form FDA 2253, so each release that changes output must fit into the company's promotional review process.
- Screens and messages: Text, charts and notifications the patient or clinician sees.
- Reports: Summaries generated for clinicians from patient or device data.
- Audio and video: Spoken instructions or training videos inside the app.
- Not output: Underlying code, data storage and back-end logic that users do not see directly.
When does a companion app become a medical device?
A companion app may also be a medical device when its software functions meet the device definition, such as analyzing patient data to recommend a dose or detect a condition. Those functions can be subject to device requirements in addition to the labeling rules that apply to its output.
Simple functions such as reminders, logging and general education usually stay on the labeling side. Functions that calculate a dose from patient data, interpret sensor readings to guide treatment, or diagnose a condition raise device questions. The boundary deserves an early regulatory assessment, because device requirements affect design controls, testing and the submission plan.
Architecture can help. Separating device functions into a distinct module with its own requirements and validation keeps the regulated scope clear and lets non-device features change on a faster release cycle.
Which privacy rules apply to pharma apps?
Many pharma companion apps are not covered by HIPAA, because the drug maker is not a health plan, clearinghouse or provider and the app is offered directly to consumers. Those apps can fall under the FTC's Health Breach Notification Rule, along with state consumer health privacy laws.
Under 16 CFR 318.5, companies covered by the rule must notify affected individuals and the FTC after discovering a breach. Breaches involving fewer than 500 people may be recorded in a log and submitted to the FTC once a year. If 500 or more residents of one state or jurisdiction are affected, notice must also go to prominent media outlets serving that area.
The rule also shapes how apps store contact details. Notice to individuals goes by email only if the user chose email as their primary contact method, otherwise by first-class mail. If contact information for ten or more people is missing or out of date, the company must provide substitute notice through a conspicuous website posting for 90 days or major print or broadcast media, with a toll-free number that stays active for at least 90 days.
That makes registration design a compliance question. An app that collects only a username and a device token may have no reliable way to reach users after a breach, which pushes the company toward public notice.
- Consent: Clear, specific consent for any data sharing, including with analytics and advertising partners.
- Minimal tracking: No third-party advertising trackers in screens that reveal health conditions.
- Data inventory: A record of what data goes where, so a breach can be assessed quickly.
- Incident plan: A tested process for deciding whether an event is a reportable breach.
How should a pharma companion app be built?
A pharma companion app should be built so that user-facing content is managed separately from code, every output change goes through medical, legal and regulatory review, data collection is consented and minimal, and any device functions are isolated and validated. This lets the app evolve without breaking compliance.
- Content management: Screens and messages stored as reviewed content with version history and approval records.
- Review integration: Releases linked to promotional review, with first-use dates captured for submission.
- Labeling sync: Content flagged for review automatically when the prescribing information changes.
- Adverse event capture: A route for reporting possible adverse events that users mention in the app.
- Evidence capture: Usage and outcome data collected with consent, ready to support claims if needed.
Adverse event handling needs particular care. Drug makers have reporting obligations when they learn of adverse events, and an app that collects free-text symptoms or messages becomes a source of such reports. The intake design should route possible events to the safety team without depending on users to use the right words.
How should a drug maker measure a companion app?
A drug maker should measure a companion app by whether it helps patients start and stay on therapy safely, not by downloads. Useful measures link app use to outcomes the brand and medical teams care about, collected with consent and analyzed without exposing individual users.
- Activation: Share of patients who complete setup after receiving the app.
- Retention: Share still using the app after one, three and six months.
- Persistence: Therapy continuation among app users compared with a suitable comparison group.
- Task success: Completion rates for key tasks such as logging a dose or finishing an injection guide.
- Safety signals: Number of possible adverse events routed to pharmacovigilance and time to routing.
Plan the evidence early if the company may want to make claims about the app's benefit. Claims about outcomes need data collected under a defined plan, which is much harder to assemble after the fact from routine app logs.
Where pharma digital programs fail
- Content in code: Screens hard-coded by developers, so every text change means a full release and a review scramble.
- Marketing trackers: Advertising tools embedded in screens that reveal a user's condition.
- No safety route: Symptom entries and messages that never reach pharmacovigilance.
- Late regulatory input: Device or labeling questions raised after the app is built.
- Weak engagement: Apps that patients open once, because they add work rather than removing it.
The last point matters most for value. A companion app earns continued use when it saves the patient time or worry, such as easing injection anxiety or simplifying refills, not when it repeats information from the leaflet.
How Agnotic can help
Drug-adjacent software has to satisfy regulatory, safety and privacy teams as well as patients. Agnotic Technologies builds digital therapeutics and drug companion software with content management tied to promotional review, labeling-change alerts, adverse event intake and consent-based data collection.
Where software functions may be devices, Agnotic separates them into validated modules with design controls and test evidence, so regulated scope stays clear while the rest of the product moves quickly.
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