{
  "node_id": "digital-therapeutics-dtx-regulation-2026",
  "title": "Digital Therapeutics (DTx) - Regulatory Classification & Market Access (2026)",
  "domain": "Medical & Healthcare",
  "version": "1.0.0",
  "last_updated": "2026-05-20",
  "bluf": "Digital Therapeutics are software-driven interventions that deliver evidence-based therapeutic treatments for medical conditions. They are regulated as medical devices (often SaMD) in most jurisdictions, requiring clinical evidence of safety and efficacy, quality management systems, cybersecurity, and post-market surveillance. Reimbursement pathways (FDA Breakthrough, German DiGA, etc.) increasingly require real-world evidence and health economic data.",
  "paywall": {
    "status": "LOCKED",
    "unlock_cost_usd": "0.01",
    "skyfire_id": "41779894-ece2-4163-9761-b3b1b76e19b0"
  },
  "crosswalks": {
    "_available_keys": [
      "nist_framework",
      "iso_standard",
      "industry_mapping",
      "ai_overlay_2026"
    ],
    "_note": "Full crosswalk values included in vault response"
  },
  "primary_citations_count": 4
}