{"h1":"What is the clinical and regulatory basis of TherapySphere™?","faq":[{"a":"No. TherapySphere™ is a care-delivery and documentation environment supporting clinician workflow, and is positioned outside the SaMD classification. It does not, of itself, drive diagnostic or treatment decisions. The separate clinician-administered AbilityScore® assessment sits within the regulated CDSCO Class B SaMD estate.","q":"Is TherapySphere™ a medical device?"},{"a":"It operationalises functioning-led care in the spirit of the WHO ICF, measurable goal-directed intervention consistent with ASHA and AAP guidance, and multi-disciplinary coordination across speech, occupational, behavioural and developmental inputs around one child's plan.","q":"What clinical frameworks underpin TherapySphere™?"},{"a":"No. Developmental measurement supports care planning; diagnosis requires an appropriately qualified healthcare professional. under qualified clinician care — never from the platform alone. TherapySphere™ supports planning, documentation and coordination, not diagnostic determination.","q":"Can TherapySphere™ produce a diagnosis?"}],"lang":"en","slug":"what-is-the-clinical-and-regulatory-basis-of-therapysphere","title":"What is the clinical and regulatory basis of TherapySphere™?","entity":{"key":"therapysphere","kind":"component","name":"TherapySphere™","slug":null},"lenses":[{"kind":"stakeholder","label":"Doctor","value":"doctor"},{"kind":"intent","label":"Definition","value":"definition"},{"kind":"lifecycle","label":"Measure","value":"measure"},{"kind":"route","label":"Book-Assessment","value":"book-assessment"},{"kind":"component","label":"Therapysphere","value":"therapysphere"},{"kind":"empowerment","label":"Family Empowerment","value":"family_empowerment"}],"parent":null,"related":[{"lang":"en","slug":"what-is-the-clinical-and-regulatory-basis-of-therapeuticai","title":"What is the clinical and regulatory basis of TherapeuticAI®?"},{"lang":"en","slug":"how-does-therapysphere-work-in-clinical-practice","title":"How does TherapySphere™ work in clinical practice?"},{"lang":"en","slug":"what-is-the-clinical-and-regulatory-basis-of-pinnacle-blooms-network","title":"What is the clinical and regulatory basis of Pinnacle Blooms Network®?"},{"lang":"en","slug":"how-does-therapysphere-improve-outcomes-and-reduce-downstream-cost","title":"How TherapySphere™ improves outcomes and reduces downstream cost"},{"lang":"en","slug":"what-is-therapysphere-at-pinnacle-blooms-network","title":"What is TherapySphere™ at Pinnacle Blooms Network?"},{"lang":"en","slug":"what-is-the-clinical-and-regulatory-basis-of-abilityscore","title":"What is the clinical and regulatory basis of AbilityScore®?"}],"summary":"TherapySphere™ is Pinnacle Blooms Network's integrated therapy-delivery and care-coordination environment, supporting clinicians to plan, document and measure goal-directed developmental therapy. Its clinical basis draws on the WHO ICF functioning model and ASHA/AAP outcome-oriented practice principles. Regulatorily it sits outside the SaMD boundary — it supports clinician workflow rather than driving diagnosis, which remains a clinician-led act performed at a centre, distinct from the CDSCO Class B SaMD AbilityScore® assessment.","answer_md":"*TherapySphere™ is the clinical operating environment in which therapy is planned, delivered and measured across Pinnacle Blooms Network — built on established developmental science and governed within India's regulatory framework.*\n\n## In short\n**TherapySphere™** is Pinnacle Blooms Network's integrated therapy-delivery and care-coordination environment — the workflow layer that helps clinicians plan goals, document sessions, track progress and align multi-disciplinary care. Its **clinical basis** rests on widely accepted developmental and rehabilitation frameworks (WHO ICF functioning model, ASHA/AAP practice principles, and goal-directed, measurable intervention). Its **regulatory positioning** is deliberately **outside the SaMD boundary**: TherapySphere™ supports clinician workflow and is not itself a diagnostic or medical-decision device — diagnostic determinations remain a clinician-led act performed at a centre.\n\n## Clinical basis\nTherapySphere™ operationalises three established principles. First, **functioning-led care** — therapy targets are framed around participation and activity in the spirit of the WHO ICF, not deficit lists alone. Second, **measurable, goal-directed intervention** — each session is anchored to defined objectives with structured progress capture, consistent with ASHA and AAP guidance on outcome-oriented developmental therapy. Third, **multi-disciplinary coordination** — speech, occupational, behavioural and developmental inputs are coordinated around one child's plan. The platform is informed by the network's operational scale: 2.5 billion+ data points, 25 million+ therapy sessions and 4.95 lakh+ families served across 70+ centres in 4 states, with 700+ therapists, supported by 16+ WIPO PCT patents and 12 validated studies. These figures describe delivery scale; they are not a substitute for individual clinical judgement.\n\n## Regulatory positioning\nIt is important to distinguish the components. The clinician-administered structured assessment that produces an **AbilityScore®** sits within the network's regulated software estate (**CDSCO Class B SaMD**). TherapySphere™, by contrast, is a **care-delivery and documentation environment** — it organises clinician workflow, records and coordination, and falls **outside the SaMD classification** because it does not, of itself, drive diagnosis or treatment decisions. This separation is intentional: it keeps medical determinations firmly in the hands of qualified clinicians while giving teams a consistent, auditable framework for delivery.\n\n## The Pinnacle way\nDevelopmental measurement supports care planning; diagnosis requires an appropriately qualified healthcare professional., under qualified clinician care — never from an app, a form or the TherapySphere™ environment alone. Clinicians can review how structured measurement works at [the AbilityScore® explainer](/ask/what-is-the-abilityscore-and-how-is-it-calculated), see delivery within [speech therapy](https://www.pinnacleblooms.org/top-speech-therapy-center-india-proven-improvement-rate), and explore partnership and onboarding via [our network](/).\n\n## Trusted sources\nWHO International Classification of Functioning, Disability and Health (ICF) for the functioning-led model; the American Speech-Language-Hearing Association on outcome-oriented therapy practice; the American Academy of Pediatrics on developmental intervention principles; CDSCO software-as-a-medical-device classification guidance for the regulatory distinction.\n\n**Next step —** If you are a clinician or institution evaluating coordinated therapy delivery, arrange a professional briefing to review how TherapySphere™ and AbilityScore® fit together within your care pathway.\n\nThis is general information, not a diagnosis — individual assessment and diagnosis require an appropriately qualified healthcare professional.","canonical":"https://pinnacleblooms.org/ask/what-is-the-clinical-and-regulatory-basis-of-therapysphere","editorial":{"reviewed_at":"2026-06-11T20:12:18.613642+00:00","reviewed_by":null,"developed_by":"SETU Consortium · Pinnacle Blooms Network"},"alternates":[{"href":"https://pinnacleblooms.org/ask/what-is-the-clinical-and-regulatory-basis-of-therapysphere","lang":"en","indexable":true}],"dimensions":[],"meta_title":"TherapySphere™: Clinical & Regulatory Basis","meta_robots":"index, follow, max-image-preview:large","everyday_tip":"When evaluating any therapy platform, separate the documentation/workflow layer from any component that drives diagnosis or treatment — they carry different regulatory obligations.","published_at":"2026-06-10T14:12:00.219358+00:00","reading_paths":[{"key":"understand","items":[{"lang":"en","slug":"what-is-the-clinical-and-regulatory-basis-of-pinnacle-blooms-network","title":"What is the clinical and regulatory basis of Pinnacle Blooms Network®?","reason":"Linked from this answer"},{"lang":"en","slug":"what-is-the-clinical-and-regulatory-basis-of-therapeuticai","title":"What is the clinical and regulatory basis of TherapeuticAI®?","reason":"Linked from this answer"},{"lang":"en","slug":"what-is-the-clinical-and-regulatory-basis-of-abilityscore","title":"What is the clinical and regulatory basis of AbilityScore®?","reason":"Linked from this answer"},{"lang":"en","slug":"what-is-the-evidence-base-for-therapysphere","title":"What is the evidence base for TherapySphere™?","reason":"Same topic"},{"lang":"en","slug":"what-is-therapysphere-and-how-does-it-help-my-child","title":"What is TherapySphere™, and how does it help my child?","reason":"Same topic"}],"label":"Understand the subject","total":5},{"key":"causes","items":[{"lang":"en","slug":"how-does-therapysphere-improve-outcomes-and-reduce-downstream-cost","title":"How TherapySphere™ improves outcomes and reduces downstream cost","reason":"Linked from this answer"}],"label":"Explore causes & influences","total":1},{"key":"assess","items":[{"lang":"en","slug":"how-does-therapysphere-measure-or-track-a-child-s-progress","title":"How TherapySphere™ Measures or Tracks a Child's Progress","reason":"Same topic"}],"label":"Understand assessment","total":1},{"key":"therapy","items":[{"lang":"en","slug":"how-does-therapysphere-work-in-clinical-practice","title":"How does TherapySphere™ work in clinical practice?","reason":"Linked from this answer"},{"lang":"en","slug":"what-is-therapysphere-at-pinnacle-blooms-network","title":"What is TherapySphere™ at Pinnacle Blooms Network?","reason":"Linked from this answer"},{"lang":"en","slug":"how-can-therapysphere-support-a-child-in-the-classroom","title":"How TherapySphere™ supports a child in the classroom","reason":"Same topic"},{"lang":"en","slug":"how-can-therapysphere-support-child-development-at-population-scale","title":"How TherapySphere™ supports child development at population scale","reason":"Same topic"},{"lang":"en","slug":"how-do-we-access-therapysphere-at-pinnacle-blooms-network","title":"How do we access TherapySphere™ at Pinnacle Blooms Network?","reason":"Same topic"},{"lang":"en","slug":"how-does-therapysphere-support-my-child-s-path-to-a-self-sufficient-mainstream-life","title":"How TherapySphere™ supports your child's path to a self-sufficient, mainstream life","reason":"Same topic"}],"label":"Explore therapy & support","total":6}],"what_to_watch":"Distinguish the regulated AbilityScore® assessment (CDSCO Class B SaMD) from TherapySphere™ as a care-delivery and documentation environment that falls outside SaMD classification.","authority_links":[{"url":"https://icd.who.int","label":"WHO ICF — functioning, disability and health classification"},{"url":"https://www.asha.org","label":"ASHA — outcome-oriented therapy practice"},{"url":"https://www.aap.org","label":"AAP — developmental intervention principles"}],"last_reviewed_at":"2026-06-10T14:12:00.219358+00:00","meta_description":"TherapySphere™ is Pinnacle Blooms Network's therapy-delivery environment — built on WHO ICF and ASHA/AAP principles, positioned outside the SaMD boundary.","related_materials":[],"related_techniques":[]}