Keep the platform open, regulate only the therapy module: Jarame’s FDA strategy is separation

[Technology · 2026-08-17]

Layer the AI Digital Care Log into source records, RWE, and a treatment engine. After authorization, expand by indication.

The core of Jarame’s FDA preparation is not “make the whole platform a device.” It is independence of the treatment function. Matching, records, and education stay. Only functions that directly affect patient outcomes become separate device software.

Jarame is not a single digital-therapy app. It holds treatment records, guardian observation, therapist ratings, center operations, home-therapy matching, counseling, education, person-level analysis, treatment recommendations, and long-term collection. Filing all of that as one FDA product would let a small admin change touch device change evaluation, and would explode the user types and environments that trials and usability studies must cover.

Why FDA talks about multiple-function products

When device and non-device functions live in one product, FDA may treat it as a Multiple Function Device Product. Even a non-device function can fall into safety and effectiveness review if it affects the device function’s input data, code, memory, performance, or cybersecurity. FDA evaluates data dependence, shared resources, and risk propagation, and may expect modularization. (U.S. Food and Drug Administration)

Six layers

1. Jarame Platform: membership, center search, home-therapy matching, schedule, payment, counseling, communication, general education. Non-device services that do not diagnose or choose a person’s treatment.
2. AI Digital Care Log Core: source data from guardians, therapists, centers, and hospitals, plus identifiers, consent, access, origin, time, and change history. It proves when, by whom, and on which system version a record was made, rather than judging treatment effect by itself.
3. AI Digital Care Log Evidence: turns source data into researchable RWD and then into RWE that can answer a regulatory question. Inclusion, baseline, exposure, concomitant therapy, missingness, follow-up, comparators, and endpoints live here.
4. Jarame Clinical: shows clinicians change, risk signals, missing data, possible interventions, and grounds. The algorithm must show which information and criteria it used, and how uncertain it is—not a bare conclusion.
5. Jarame Therapeutic: the direct FDA subject. Content choice, order, difficulty, frequency, and next intervention that engage outcomes. The first file should freeze one age, diagnosis, goal, and endpoint—not all developmental disability.
6. Jarame Quality & Safety: complaints, malfunctions, adverse events, CAPA, model drift, cybersecurity, and post-market safety and performance. Real-time collection can serve pre-market trials and post-market surveillance.

Separation must be technical, not cosmetic

Renaming menus is not enough. The filed module needs clear boundaries in source, database, APIs, permissions, deployment, configuration management, algorithm version, and audit logs. A platform fault must not change therapeutic calculation or output. If the two sides share data, the share range and error controls belong in risk-management documents.

Model updates change too. The first authorized product would freeze the approved model, preprocessing, and protocol as the regulatory baseline. New data would be trained in a separate research environment, then released only after independent validation and risk review. FDA’s Predetermined Change Control Plan (PCCP) lets a sponsor pre-define what performance to improve, with which data, and how to verify impact—important for a system that learns from use. (U.S. Food and Drug Administration)

Software documents become a traceability chain

Requirements, design, risk controls, code, verification, validation, and clinical evidence must connect. FDA premarket software documentation typically covers description, risk management, requirements, architecture, testing, version history, and unresolved anomalies. (U.S. Food and Drug Administration)

The gain is clear. The platform can still ship quickly. The AI Digital Care Log stays a shared RWD/RWE base across conditions. The authorized module stays strict for that indication, then the family can grow to communication, behavior, daily living, and sleep. The competitive edge is not one therapy app. It is connecting state before treatment, the intervention, everyday response, and long-term outcome—and feeding that back into improvement and post-market watch. See also the FDA entry preparation notice.