01Purpose and roles
The U.S. operator organizes the Navelia platform and entrusted case services. The China operating partner acts only on written instructions for defined patient tasks. The parties must execute an applicable downstream BAA according to the actual PHI relationship and confirm upstream permission for subcontracting. A Chinese hospital delivering its own care is treated as an independent healthcare recipient. Different functions performed by one organization require separate role and access determinations. This addendum does not establish any unobtained HIPAA certification, professional license, or governmental approval.
02The two data routes
Route A is remote access from China by named personnel to assigned case information in U.S. systems, where original platform records remain. Route B is transmission of a reviewed minimum-data package to a named recipient; permitted downloading or temporary processing may create recipient copies. Both require access and disclosure assessment. The absence of downloading in Route A does not eliminate overseas access. Route B transfers, temporary copies, independent hospital records, and platform backups must be documented separately rather than described as all copies residing only in the United States.
03Task-based minimum scope
Each row is a review example, not pre-authorization to disclose.
| Task | Candidate necessary information | Exclude or justify separately |
|---|---|---|
| Initial availability enquiry | Specialty need, necessary reviewed question, non-identifying description where sufficient. | Name, passport, complete original records and unrelated history. |
| Professional case pre-review | Reviewed summary, relevant tests, key medicines and allergies; original imaging if professionally necessary. | Payment details, credentials, unrelated family identities and unnecessary historical files. |
| Appointment and identity | Necessary identity fields requested by the hospital, timing and contact route. | Default full passport copies or complete records; separately explain any required ID copy. |
| Transport, accommodation and reception | Timing, locations, necessary contact and assistance needs. | Diagnoses, imaging, mental, sexual, genetic and unrelated health details. |
| Hospital treatment | Scope established by lawful clinical need and a separate disclosure arrangement. | Do not omit clinically necessary facts under an administrative minimization rule; exclude platform administration information. |
| Discharge and follow-up | Discharge summary, medicines and follow-up details needed by the verified recipient. | Unrelated billing, internal review discussions, other patients' information and database exports. |
Initial availability enquiry
- Candidate necessary information
- Specialty need, necessary reviewed question, non-identifying description where sufficient.
- Exclude or justify separately
- Name, passport, complete original records and unrelated history.
Professional case pre-review
- Candidate necessary information
- Reviewed summary, relevant tests, key medicines and allergies; original imaging if professionally necessary.
- Exclude or justify separately
- Payment details, credentials, unrelated family identities and unnecessary historical files.
Appointment and identity
- Candidate necessary information
- Necessary identity fields requested by the hospital, timing and contact route.
- Exclude or justify separately
- Default full passport copies or complete records; separately explain any required ID copy.
Transport, accommodation and reception
- Candidate necessary information
- Timing, locations, necessary contact and assistance needs.
- Exclude or justify separately
- Diagnoses, imaging, mental, sexual, genetic and unrelated health details.
Hospital treatment
- Candidate necessary information
- Scope established by lawful clinical need and a separate disclosure arrangement.
- Exclude or justify separately
- Do not omit clinically necessary facts under an administrative minimization rule; exclude platform administration information.
Discharge and follow-up
- Candidate necessary information
- Discharge summary, medicines and follow-up details needed by the verified recipient.
- Exclude or justify separately
- Unrelated billing, internal review discussions, other patients' information and database exports.
Highly sensitive information, whole-genome or other omic data, psychotherapy notes, potentially Part 2-protected records, minors' information, and government-related data must not be sent under a generic task template without specific determination of applicable conditions. Coding data does not automatically remove PHI or other sensitive-data protections.
04The authorization record
Before first access, disclosure to a new recipient, a new purpose, or expanded scope, record the patient and case, principal authority, required patient authorization, recipient organization and personnel, country, task, fields and files, version, time window, permitted actions, channel, copying and disposal arrangements, approver, execution, and result. Case permission does not authorize access to another case. Authorization must remain valid at execution; historical consent, an unverified chat message, or a contract template alone is not sufficient evidence of authorized disclosure.
05Remote-access restrictions
Use named accounts, multi-factor authentication, case assignment, least privilege, and expiry-based revocation without shared credentials. Downloading, copying, printing, screenshots, clipboard, synchronization, and export permissions are controlled separately by task and prohibited without permission; visibility is not permission to retain. Work endpoints require appropriate device and security management. The China operator receives no platform-wide database, backup, key, complete identity mapping, or unrelated internal review access. Changes and abnormal access must be traceable, and material unresolved concerns suspend access.
06Packages and transmission channels
Packages are assembled in the controlled U.S. environment and contain only approved versions and files. Verify recipient addresses or accounts before sending through channels with appropriate encryption, identity verification, and expiry controls. PHI must not be delivered through personal email, personal messaging, public links, or unapproved cloud drives, or uploaded to public AI for convenience. Record delivery and receipt outcomes; link creation or attempted sending is not confirmed receipt. Revoke revocable access to cancelled, expired, or misaddressed packages, investigate whether copies were obtained, and remediate.
07Temporary copies, hospital records, return and deletion
If Route B requires temporary copies, identify the holder, protected environment, purpose, permitted duration, and deletion responsibility in advance. The China operator may not create a default long-term mirror database, back up copies into other regions, or retain them for possible future usefulness. On completion, expiry, or termination, return or delete under the applicable BAA and instructions and provide verifiable results. Required legal preservation must identify its basis, scope, and end condition, stop other uses, and notify the authorized party. Statutory records created by a hospital's independent care are governed by its separate notice, not misrepresented through promises about deletion of operational copies.
08Further subcontracting and disclosure
The China partner may not independently pass information to another hospital, contractor, software provider, or affiliate. New recipients or subprocessors require U.S. operator and applicable upstream review, required BAA, confidentiality, purpose, regional and security obligations, and necessary patient notices and permissions. Common group ownership is not automatic sharing authority. Sale, independent marketing, research, teaching, model training, and attempts to re-identify restricted-identity information are prohibited. Patient consent does not waive applicable legal prohibitions.
09Incident reporting and investigation
On discovering misdelivery, excessive access, credential compromise, unauthorized copying, or another potential information incident, the China party promptly contains the issue and notifies the U.S. operator without unreasonable delay under the stricter applicable BAA and contractual deadline. Initial reporting must not await a complete root cause or affected-person count. The parties specify initial content, updates, evidence preservation, recipient coordination, notification responsibilities, and remediation verification. Necessary evidence must not be destroyed or conflicting statements issued to patients. The executed contract must state an initial-reporting deadline and continuous escalation contacts.
10Withdrawal and patient requests
On receiving withdrawal, access, correction, or deletion requests, the China party promptly forwards them to the U.S. operator and authorized principal and stops future relevant actions as instructed. It must not independently deny rights, promise deletion outside its authority, or disclose records directly to an unverified requester. Lawfully created medical records, legal holds, and BAA duties are handled separately; recovery of every prior authorized disclosure cannot be guaranteed. Forwarding does not reset legal deadlines. Retain minimum necessary evidence of suspension, return, or deletion outcomes.
11Independent legal assessment and audit
The parties assess applicable U.S. and Chinese sensitive-data, medical, access, and cross-border requirements. U.S. Data Security Program applicability depends on data, parties, access, transaction type, scale, exceptions, and other facts. U.S. storage, case-by-case viewing, patient consent, or a BAA alone does not remove the need for assessment. Sending newly created Chinese medical information to the United States also requires separate assessment. Retain necessary contract, permission, training, access, transfer, deletion, and audit evidence and allow reasonable agreed review, with audit material itself minimized and protected.
12Changes and termination
Changes to purposes, personnel scope, recipients, regions, channels, or copying rules require review before implementation. At termination, revoke accounts, links, and task permissions and address return/deletion, required preservation, patient continuity, and surviving confidentiality duties. Continuing necessary hospital handoffs require separate lawful arrangements: contract termination must neither abandon patient records nor justify indefinite access in the name of continuity.
13Patient-specific authorization template
This template concerns a defined disclosure or limited period and is not signed merely by accepting the Terms or Privacy Policy. Where a HIPAA Authorization is required, the executed form must satisfy all applicable elements of 45 CFR 164.508 and other special protections. Research or marketing must not be bundled into an indivisible choice with this coordination activity.
| Required item | Completion |
|---|---|
| Patient and request | Patient name and case reference; additional verification information only as necessary. |
| Authorized discloser | Specific U.S. entity, commissioning organization or lawful class, and contact method. |
| Recipient | Specific China entity, department or person, address/contact, and processing country. |
| Purpose | Explain the particular task in understandable language. |
| Information | Specify fields, files, versions, date range and exclusions. |
| Route | Separately select remote viewing, specified downloads or a minimum-data package; no automatic selection of all routes. |
| Retention and copies | U.S. original storage; recipient-copy environment, duration, deletion and statutory-record exceptions. |
| Expiry | A definite date or event related to the patient or disclosure purpose. |
| Revocation | Actual route for written revocation and exceptions for action already taken in reliance on valid authorization. |
| Effect of refusal | Identify any step requiring sharing, unaffected services, and conditions prohibited by law. |
| Redisclosure notice | Information may be redisclosed and may no longer be protected by HIPAA; other agreements and applicable laws may still restrict the recipient. |
| Signature | Patient signature/date; representative identity and explanation of authority where applicable; provide an executed copy. |
Patient and request
- Completion
- Patient name and case reference; additional verification information only as necessary.
Authorized discloser
- Completion
- Specific U.S. entity, commissioning organization or lawful class, and contact method.
Recipient
- Completion
- Specific China entity, department or person, address/contact, and processing country.
Purpose
- Completion
- Explain the particular task in understandable language.
Information
- Completion
- Specify fields, files, versions, date range and exclusions.
Route
- Completion
- Separately select remote viewing, specified downloads or a minimum-data package; no automatic selection of all routes.
Retention and copies
- Completion
- U.S. original storage; recipient-copy environment, duration, deletion and statutory-record exceptions.
Expiry
- Completion
- A definite date or event related to the patient or disclosure purpose.
Revocation
- Completion
- Actual route for written revocation and exceptions for action already taken in reliance on valid authorization.
Effect of refusal
- Completion
- Identify any step requiring sharing, unaffected services, and conditions prohibited by law.
Redisclosure notice
- Completion
- Information may be redisclosed and may no longer be protected by HIPAA; other agreements and applicable laws may still restrict the recipient.
Signature
- Completion
- Patient signature/date; representative identity and explanation of authority where applicable; provide an executed copy.
Proposed confirmation
“I understand the information, recipient, purpose, access or transfer route, and possible controlled recipient copies described above. I authorize the identified discloser to provide the selected information to the recipient for the stated purpose and period. I understand how to revoke, the actual effect of refusal, and that lawfully disclosed information may not be fully recoverable. This authorization does not include other purposes, unlisted recipients, marketing, or general-purpose model training.”