Behavioral & mental health
Digital therapeutics for mental health, such as CBT-based programs for depression, anxiety and substance use.
Digital Therapeutics
Evidence-based digital therapeutics engineered for the FDA pathway
We build DTx products that deliver clinical-grade interventions and measure outcomes, architected for the FDA Software as a Medical Device (SaMD) pathway, with the evidence and quality system a regulated product needs.
HIPAA-ReadyFDA SaMDIEC 62304Evidence-Based
Trusted by global innovators
What are digital therapeutics?
Digital therapeutics (DTx) are software that delivers an evidence-based intervention to prevent, manage or treat a medical condition, and measures the outcome. When a DTx makes a therapeutic claim, FDA can regulate it as a medical device. Agnotic Technologies builds DTx software for founders and pharma teams, with the evidence and quality records a submission needs.
That is what separates a DTx from general wellness content. Interventions are versioned and traceable, outcomes are instrumented for clinical studies, and the system follows IEC 62304 for the software lifecycle and ISO 13485 for the QMS.
What it is
Software that treats, backed by evidence
A digital therapeutic delivers an evidence-based clinical intervention to prevent, manage, or treat a condition, and measures defined outcomes to prove it works.
When it makes therapeutic claims, it is regulated as Software as a Medical Device. We build DTx products under a device-grade quality system so the software, evidence, and FDA pathway move forward together.
DTx architecture
See how we connect evidence-based intervention delivery, outcome measurement, and the SaMD quality system across the DTx products we build.
What do we build into digital therapeutics software?
Each capability ties an intervention to the evidence or regulation that makes it a therapeutic, not an app.
Evidence-based intervention engine
Versioned, traceable delivery of clinical protocols (CBT modules, behavior-change programs, or condition-specific regimens) mapped to the evidence base they're built on.
Outcome measurement
Validated instruments (PHQ-9, GAD-7, A1C, and disease-specific PROs) instrumented from day one to power clinical studies and demonstrate therapeutic effect.
FDA SaMD quality system
Software lifecycle under IEC 62304, a risk file per ISO 14971, and an ISO 13485-aligned QMS so the product is submission-ready rather than reverse-engineered before filing.
Engagement & adherence
Clinical-grade engagement design (reminders, personalization, and adherence tracking) because a therapeutic only works if patients actually complete the program.
EHR & prescribing integration
FHIR-based integration for prescription digital therapeutics (PDTs) so clinicians can prescribe, and results flow back to the chart as structured data.
PHI security & consent
Encryption at rest and in transit, granular consent, and audit logging so sensitive behavioral and clinical data is protected to HIPAA standards throughout.
Where it runs
Which conditions do DTx products target?
Chronic disease management
Evidence-based programs for diabetes, hypertension, and COPD.
Prescription DTx (PDT)
Clinician-prescribed therapeutics with EHR integration.
Pain management
Non-pharmacological digital interventions for chronic pain.
Sleep & metabolic health
Structured programs targeting insomnia and metabolic outcomes.
Pharma companion products
DTx paired with a drug to improve adherence and outcomes.
Therapeutics engineered for evidence
DTx products fail when engineering ignores the regulatory and evidence path. We build the intervention, the measurement, and the quality system together.
FDA SaMD
Software as a Medical Device pathway
IEC 62304
Medical-device software lifecycle
Validated PROs
Outcome measurement built in
Compliance-First Healthcare App Development Services Backed by Global Standards
15-Minute Scoping Call01
HIPAA
Health Insurance Portability and Accountability Act
Protect PHI with privacy-first architecture, encrypted storage and transmission, strict access controls, and traceable audit logs.
02
GDPR
General Data Protection Regulation
Implement lawful consent flows, data minimization, retention controls, and secure processing for sensitive health data.
03
FHIR
Fast Healthcare Interoperability Resources
Enable standardized health data exchange across apps, care teams, and systems through standards-based FHIR APIs.
04
HL7
Health Level Seven International
Support enterprise-grade interoperability with HL7-based integrations for records, events, and clinical messaging workflows.
05
HITRUST
Health Information Trust Alliance
Align security programs to healthcare-specific control and risk management practices trusted by providers and ecosystem partners.
06
HITECH
Health Information Technology for Economic and Clinical Health Act
Design with breach notification readiness, digital record safeguards, and operational controls that support regulated care programs.
07
SaMD
FDA Software as a Medical Device
Plan software quality, traceability, and documentation pathways for products that may require SaMD review and submission.
08
MDR (EU)
Medical Device Regulation (European Union)
Prepare EU market-ready processes for risk classification, evidence tracking, and lifecycle governance under MDR expectations.
09
SAMHSA
Substance Abuse and Mental Health Services Administration
Apply confidentiality controls and consent-aware sharing models for behavioral and mental health data experiences.
Standards we build against
Which standards apply to DTx software?
SaMD623041497113485HIPAA
Our Process
How do we build digital therapeutics?
Intervention, evidence measurement, and the regulatory quality system advance in parallel so software and submission stay aligned.
1.
Discovery & regulatory strategy
We define the intervention, clinical claims, and FDA SaMD classification, then design the evidence and quality plan before building.
Evidence-first design
2.
Intervention & measurement
We build the versioned intervention engine and instrument validated outcome measures to support the clinical study.
Clinical-grade core
3.
Quality system & integration
We develop under IEC 62304 with a risk file and QMS, and build EHR/prescribing integration for PDT workflows.
Submission-ready
4.
Validation & launch
Verification and validation, human-factors testing, and phased launch with engagement and outcome dashboards.
Always audit-ready
Facts and sources
What do FDA and HIPAA rules require of a DTx?
Short facts we design digital therapeutics around, each linked to its primary source.
FDA's guidance on device software functions focuses oversight on software that meets the definition of a medical device and could put patient safety at risk if it does not work as intended.
Source: FDA, Policy for Device Software Functions and Mobile Medical Applications (2022)Section 524B of the FD&C Act sets cybersecurity requirements for cyber devices, and FDA guidance describes the cybersecurity documentation it recommends in premarket submissions for devices with cybersecurity risk.
Source: FDA, Cybersecurity in Medical Devices42 CFR Part 2 restricts the use and disclosure of substance use disorder patient records maintained by federally assisted Part 2 programs, separately from the HIPAA Privacy Rule.
Source: 42 CFR Part 2 (eCFR)The HIPAA Security Rule requires administrative, physical and technical safeguards for electronic protected health information.
Source: 45 CFR Part 164 Subpart C (eCFR)
Featured case study
Read Case StudyLera Health: compliant women's health platform
Related proof of compliant delivery: on Lera Health we turned biomarker data into personalized, compliant care plans, the same evidence-to-experience discipline and PHI rigor a digital therapeutic depends on.
Why Partner With Us
15-Minute Scoping CallWhy build DTx with Agnotic?
DTx is a product and a regulated device at once. We bring the engineering and the quality discipline to build both.
Regulatory-aware by default
IEC 62304, ISO 14971 risk management, and an ISO 13485 QMS built into delivery from sprint one, not reconstructed before an FDA filing.
Evidence & product depth
We design outcome measurement and intervention traceability that clinical and regulatory teams can actually build a submission on.
Engagement that retains
Behavior-change and adherence design tuned so patients complete the program: the difference between a therapeutic and shelfware.
Digital-health domain fluency
We've built across behavioral and chronic-condition products, so your team isn't educating ours on the space.
Frequently Asked Questions
A wellness or unregulated DTx is a smaller build than an FDA-regulated SaMD with a quality system and clinical-study support. Cost scales with regulatory class, the depth of the intervention, and integration needs. We scope by claims and classification, then phase the build so the intervention and measurement core come first and the quality-system artifacts scale alongside it.
It depends on your claims and regulatory class, the depth of the intervention and what the clinical study needs. FDA-regulated products take longer because verification, validation and quality-system documentation run alongside engineering. The clinical evidence timeline, not the software, usually governs the path to market, and we give you a plan after the scoping call.
Build with a partner when you need device-grade engineering discipline (IEC 62304, risk management, validated measurement) that general app teams rarely have. Keep it in-house only if you already have that quality system and regulatory capability. Many DTx companies pair their clinical and regulatory teams with an engineering partner who can build to the standard.
It depends on your claims. Software that makes therapeutic claims to treat or manage a disease is generally regulated as Software as a Medical Device and needs an appropriate FDA pathway; general wellness tools often are not. We help define claims and classification early so you build to the right bar rather than discovering the requirement late.
For prescription digital therapeutics we build FHIR-based integration so clinicians can prescribe the product from their workflow and receive outcome data back as structured resources. That closes the loop between the therapeutic and the clinical record, which matters for both care and reimbursement.
We instrument validated outcome measures (such as PHQ-9, GAD-7, or disease-specific PROs) from day one and structure data capture to support your clinical study. The evidence is engineered into the product rather than retrofitted, so the data your regulatory and payer conversations depend on is credible and complete.
Yes. Outcome scores, symptoms and prescription details are PHI, so Agnotic signs a business associate agreement before any PHI is shared with our team, and we use synthetic data in development and test environments.
Yes. The first release is scoped to one workflow, usually the core intervention with its outcome measures, so you can run a pilot or study before adding prescribing and EHR integration.
AI tools help our engineers draft code and tests, but a person reviews every change, and it passes the same automated tests and security checks as any other code. Which tools may see your code or data is agreed with you at the start.
Building an evidence-based digital therapeutic?
Tell us your intervention and clinical claims. We'll return a phased plan covering the SaMD pathway, outcome measurement, and the quality system to get there.
contact@agnotic.com
Partnerships
contact@agnotic.com