Below is a concise, practical checklist of legal, technical, and operational requirements you should consider when building or operating payment processing for a healthtech product in the United States. I’ve grouped items by category and cited authoritative sources for the most important legal/regulatory points.

Legal & regulatory (must‑follow)

• HIPAA (Privacy, Security, Breach Notification): if your system creates, receives, stores, or transmits protected health information (PHI)/ePHI you are a covered entity or a business associate and must implement administrative, physical, and technical safeguards, sign Business Associate Agreements (BAAs) with covered entities, perform risk analysis, and follow breach notification timelines. (hhs.gov)
• PCI DSS (cardholder data): if you accept, store, transmit, or process payment card data you must comply with PCI DSS controls (or use a PCI-compliant payment processor that scopes you out). PCI and HIPAA apply in parallel — you must address both when handling PHI + card data. (Use tokenization / hosted payment pages to reduce PCI scope.) (hhs.gov)
• No Surprises Act / surprise-billing and price-transparency rules: providers and facilities have notice, disclosure and “good faith estimate” obligations for self-pay/uninsured patients and restrictions on balance billing in many circumstances; compliance affects billing flows and patient notifications. CMS provides provider- and plan-level implementation guidance. (cms.gov)
• CMS EFT/ERA operating rules and standards: health plan-to-provider electronic payments must use ACH/EFT (CCD+Addenda with X12 835 remittance advice); follow CAQH/CORE and CMS guidance for EFT/ERA enrollment and data elements. If you integrate with payer payments, support X12 835 and TRN/CCD+Addenda conventions. (cms.gov)
• State laws & consumer protections: state consumer protection, data breach, telehealth billing, and privacy laws vary — check state-specific requirements where you operate (e.g., consent for balance billing, additional breach notification rules). (CMS resources and state AG / DOH sites are authoritative for state details.) (cms.gov)

Security & technical controls (required or strongly expected)

• Encryption: TLS (in transit) and strong encryption at rest for PHI and for any stored payment data (or avoid storing cards by using tokenization/PCI-hosted vaults). (hhs.gov)
• Tokenization / vaulting for card data: use PCI-certified tokenization or hosted payment forms to reduce scope and risk. (hhs.gov)
• Access control & least privilege: role-based access, MFA for staff, and strict separation between PHI and non-PHI processing systems. (hhs.gov)
• Network segmentation & logging: separate payment/card systems from clinical systems; keep immutable audit logs and retain as required for compliance/audits. (hhs.gov)
• Data minimization & retention policies: store only what’s required for business and legal needs; document retention periods (HIPAA documentation rules require 6 years for certain records). (hhs.gov)
• Secure development & vulnerability management: threat modeling, code review, pen tests, timely patching, and incident response playbooks (HIPAA Security Rule expects policies and periodic evaluation). (hhs.gov)
• Breach detection & response: procedures to identify, investigate, mitigate, and notify per HIPAA Breach Notification Rule and state breach laws; log and report breaches timely. (hhs.gov)

Privacy, consent, and patient communications

• Privacy notices & disclosures: ensure HIPAA Privacy Rule compliance (notices of privacy practices) and implement required No Surprises Act disclosures (fact sheets, onsite/online notices) where applicable. (acr.org)
• Patient authorization vs. treatment/payment/operations: only use/ disclose PHI for permitted purposes unless you have explicit patient authorization for other uses (e.g., marketing). Document authorizations. (hhs.gov)
• Good Faith Estimates & self-pay workflows: support mechanisms to create and deliver Good Faith Estimates to uninsured/self-pay patients and to track consents for out‑of‑network care where needed by the No Surprises Act. (cms.gov)

Claims, remittance & payer integrations (operational)

• Support standard EDI transactions if doing claims/adjudication: X12 837 (claims), 835 (remittance), 270/271 (eligibility), 276/277 (claims status). For payment reconciliation, support X12 835 and CCD+Addenda ACH rules. (cms.gov)
• Remittance reconciliation and ERA handling: design automated posting of ERAs to patient accounts receivable to avoid manual errors; require consistent use of CARC/RARC codes by payers. (cms.gov)
• Provider identifiers & enrollment: collect/validate NPIs, TINs, payer enrollment info; support EFT/ERA enrollment processes. (cms.gov)

Contracting & third parties

• Business Associate Agreements (BAAs): have BAAs with any third party that creates/receives/transmits ePHI (including payment processors if PHI passes through). BAAs must document obligations, breach notification, and subcontractor flow-down. (hhs.gov)
• Vendor due diligence: require evidence of PCI DSS compliance for card processors, SOC2/ISO27001 for vendors, penetration-test reports, and contractual security SLAs. (hhs.gov)
• Subcontractor flow‑down: ensure subcontractors also sign BAAs (or equivalent) and meet technical/security requirements. (hhs.gov)

Compliance, audit, and governance

• Risk analysis & management plan: perform and document formal risk analyses; address risks with remediation plans and periodic re-evaluation (HIPAA Security Rule). (hhs.gov)
• Policies, training & documentation: written policies, staff security/privacy training, sanctions policy, and documentation retention (HIPAA requires documentation retention for specified periods). (hhs.gov)
• Monitoring & periodic assessments: audits, automated monitoring, vulnerability scans, and third-party assessments (PCI external scans, penetration tests). (hhs.gov)
• Regulatory monitoring: track CMS/HHS/OCR guidance (HIPAA updates, HIPAA Security Rule NPRM), PCI SSC changes, and No Surprises Act guidance — all of these change over time. (OCR issued a Security Rule NPRM in December 2024 proposing stronger cybersecurity requirements.) (hhs.gov)

Usability & business requirements (practical)

• Transparent patient billing UI: clear cost estimates, itemized bills, easy payment options, receipts, and dispute paths (No Surprises Act requires certain notifications and disclosures). (cms.gov)
• Multi‑channel payments: support card (via PCI-compliant processor/token), ACH/EFT (for provider payouts and some patient payments), and support pay-by-link, kiosks, and in-app flows that keep card data out of your servers where possible. (cms.gov)
• Reconciliation & refund workflows: automated reconciliation between payments, ERAs, patient responsibility, and provider ledger; clear refund/void processes consistent with payer rules.
• Reporting & audit trails for payers/providers: detailed, exportable transaction and remittance reports with associated CARC/RARC interpretations to support appeals and IDR where needed. (aha.org)

Risk mitigations & recommended best practices

• Use PCI-hosted payment forms or a certified gateway to reduce PCI scope.
• Avoid storing card data unless absolutely necessary; if you must, use vaulting and tokenization from a PCI-certified provider.
• Encrypt PHI at rest and in transit; implement MFA and RBAC for staff.
• Keep payment and clinical systems logically separated and document the separation for audits.
• Implement a robust incident response plan that covers both card breaches and ePHI incidents and includes notification templates for OCR and state AGs.
• Maintain up-to-date BAAs and vendor security attestations (SOC2 reports, PCI Attestation of Compliance).

Key authoritative resources (starting points)

• HHS / OCR HIPAA materials and Security Rule summary and guidance. (hhs.gov)
• PCI Security Standards Council (PCI DSS) — standards and guidance (visit PCI SSC for most current requirements).
• CMS No Surprises Act resources and provider requirements pages. (cms.gov)
• CMS EFT/ERA operating rules (CCD+Addenda and X12 835 guidance). (cms.gov)

If you want, I can:

• Turn this checklist into a prioritized implementation plan (MVP → compliance milestones) tailored for: (a) a patient-facing telehealth app taking payments, (b) a provider practice management system integrating with payer ERAs, or (c) a billing/collections vendor — tell me which and I’ll map tasks, timeline, and estimated effort.
• Produce sample BAA language, risk-analysis checklist, or a PCI scoping approach for your architecture.

Which of those would be most helpful?