Built for the InfoSec review.
InVision processes protected health information on behalf of the health systems that deploy it. This page collects what your security, privacy, and compliance teams ask for, in the order they usually ask for it.
Certifications and attestations
InVision maintains the three programs a hospital's security and quality teams look for: an independent SOC 2 Type II attestation, a medical-device quality management system, and HIPAA safeguards.
SOC 2 Type II
An independent SOC 2 Type II examination of the controls governing the security of the systems that process customer data — tested across an observation period, not just at a point in time — audited by Johanson LLP and backed by continuous control monitoring, annual penetration testing, and cybersecurity reviews.
ISO 13485
Quality management system for the design and manufacture of medical devices — the framework under which our cleared software is developed, validated, and released.
HIPAA
Administrative, physical, and technical safeguards for protected health information, executed under a business associate agreement with each covered entity.
How PHI moves through the system
InVision is post-processing software. It reads studies your lab has already acquired and returns structured output; it does not acquire images, and it does not sit in the acquisition path.
| Stage | What happens | What leaves your network |
|---|---|---|
| IntakeDICOM routing | Completed studies route to InVision from your PACS, CVIS, or modality using standard DICOM. | On-premise: nothing. Cloud: the study, over an encrypted channel. |
| AnalysisCleared algorithms | Precision LVEF and Precision Cardiac Amyloid analyze the study and produce measurements and flags. On-premise, all inference runs locally. | Nothing beyond the deployment boundary you chose. |
| ReturnStructured results | Results return to your reporting workflow for a cardiologist to review, edit, and sign. | Nothing. Output lands back in your systems. |
| DeletionNo image retention | In an on-premise deployment, no image data is retained once processing is complete. | Nothing. |
| MeteringBilling and QC metadata | Study metadata — date, accession number, age, sex, billing codes selected, limited or comprehensive study, workflow timestamps, and reported study quality — is sent to InVision for invoice tracking and quality control. | Metadata only. No images. Held on encrypted InVision servers in the US. |
| AccountabilityEdit trail | Every report records what the model proposed and what the physician changed. | Nothing. |
Data residency and the on-premise option
Where PHI lives is a procurement and security decision, and InVision supports both answers with the same cleared algorithms.
On-premise
InVision runs inside your data center, behind your firewall, under your access controls.
- PHI never leaves your network.
- All inference runs locally; no image data is retained after processing.
- Your existing firewall and security infrastructure do not need to change.
- Model versions are pinned and updated on your change-control schedule.
Validated cloud
InVision runs in our validated cloud environment, with studies transferred over an encrypted channel.
- No local infrastructure to provision or maintain.
- Hosted on AWS, within your geographic region in the United States.
- Covered by the SOC 2 Type II scope and your executed BAA.
- Faster to stand up when data-center capacity is constrained.
Security controls
The controls below apply to InVision's own infrastructure. In an on-premise deployment they sit alongside the controls your organization already enforces on the host — they do not replace them. The three themes summarize the program; the full control set tested under our SOC 2 Type II examination is published further down.
Access
Role-based access control, least-privilege access, and multi-factor authentication.
Auditability
Audit logging across systems that process customer data, plus a complete edit trail on every clinical report.
Assurance
Annual cybersecurity reviews, penetration testing, third-party SOC 2 Type II audits, and secure software development practices.
As an FDA-cleared Software as a Medical Device, InVision also carries the post-market obligations of a device manufacturer: formal complaint intake and handling, adverse event evaluation and reporting, model performance monitoring, and version control for any approved algorithm update — governed under our ISO 13485 quality management system. Our cleared algorithms are static and cannot be modified without a new FDA clearance, so a model cannot change underneath you.
The full control set
These are the controls monitored continuously and examined by our independent auditor under the SOC 2 Type II program — 71 controls across five domains. Expand each domain to read every control and its description.
Product security 4 controls
InVision performs control self-assessments at least annually to gain assurance that controls are in place and operating effectively. Corrective actions are taken based on relevant findings. If InVision has committed to an SLA for a finding, the corrective action is completed within that SLA.
InVision uses secure data transmission protocols to encrypt confidential and sensitive data when transmitted over public networks.
InVision's formal policies outline the requirements for the following functions related to IT / Engineering:
- vulnerability management;
- system monitoring.
InVision's penetration testing is performed at least annually. A remediation plan is developed and changes are implemented to remediate vulnerabilities in accordance with SLAs.
Data and privacy 2 controls
InVision has formal retention and disposal procedures in place to guide the secure retention and disposal of InVision and customer data.
InVision has a data classification policy in place to help ensure that confidential data is properly secured and restricted to authorized personnel.
Infrastructure security 21 controls
InVision requires authentication to production datastores to use authorized secure authentication mechanisms, such as unique SSH key.
InVision restricts privileged access to encryption keys to authorized users with a business need.
InVision requires authentication to systems and applications to use unique username and password or authorized Secure Socket Shell (SSH) keys.
System access restricted to authorized access only
InVision's access control policy documents the requirements for the following access control functions:
- adding new users;
- modifying users; and/or
- removing an existing user's access.
InVision restricts privileged access to databases to authorized users with a business need.
InVision restricts privileged access to the firewall to authorized users with a business need.
InVision restricts privileged access to the operating system to authorized users with a business need.
InVision restricts privileged access to the production network to authorized users with a business need.
InVision completes termination checklists to ensure that access is revoked for terminated employees within SLAs.
InVision requires authentication to the "production network" to use unique usernames and passwords or authorized Secure Socket Shell (SSH) keys.
InVision's production systems can only be remotely accessed by authorized employees possessing a valid multi-factor authentication (MFA) method.
InVision's production systems can only be remotely accessed by authorized employees via an approved encrypted connection.
InVision uses an intrusion detection system to provide continuous monitoring of InVision's network and early detection of potential security breaches.
InVision utilizes a log management tool to identify events that may have a potential impact on InVision's ability to achieve its security objectives.
InVision's network is segmented to prevent unauthorized access to customer data.
InVision reviews its firewall rulesets at least annually. Required changes are tracked to completion.
InVision uses firewalls and configures them to prevent unauthorized access.
InVision's network and system hardening standards are documented, based on industry best practices, and reviewed at least annually.
InVision has infrastructure supporting the service patched as a part of routine maintenance and as a result of identified vulnerabilities to help ensure that servers supporting the service are hardened against security threats.
An infrastructure monitoring tool is utilized to monitor systems, infrastructure, and performance and generates alerts when specific predefined thresholds are met.
Organizational security 11 controls
InVision maintains a formal inventory of production system assets.
InVision deploys anti-malware technology to environments commonly susceptible to malicious attacks and configures this to be updated routinely, logged, and installed on all relevant systems.
InVision performs background checks on new employees.
InVision requires employees to acknowledge a code of conduct at the time of hire. Employees who violate the code of conduct are subject to disciplinary actions in accordance with a disciplinary policy.
InVision requires employees to sign a confidentiality agreement during onboarding.
InVision managers are required to complete performance evaluations for direct reports at least annually.
InVision requires passwords for in-scope system components to be configured according to InVision's policy.
InVision has a mobile device management (MDM) system in place to centrally manage mobile devices supporting the service.
InVision requires employees to complete security awareness training within thirty days of hire and at least annually thereafter.
InVision requires contractor agreements to include a code of conduct or reference to the InVision code of conduct.
InVision requires contractors to sign a confidentiality agreement at the time of engagement.
Internal security procedures 33 controls
InVision has Business Continuity and Disaster Recovery Plans in place that outline communication plans in order to maintain information security continuity in the event of the unavailability of key personnel.
InVision has a documented Business Continuity/Disaster Recovery (BC/DR) plan and tests it at least annually.
InVision has a configuration management procedure in place to ensure that system configurations are deployed consistently throughout the environment.
InVision requires changes to software and infrastructure components of the service to be authorized, formally documented, tested, reviewed, and approved prior to being implemented in the production environment.
InVision restricts access to migrate changes to production to authorized personnel.
InVision has a formal systems development life cycle (SDLC) methodology in place that governs the development, acquisition, implementation, changes (including emergency changes), and maintenance of information systems and related technology requirements.
InVision's board of directors or a relevant subcommittee is briefed by senior management at least annually on the state of InVision's cybersecurity and privacy risk. The board provides feedback and direction to management as needed.
InVision's board of directors has a documented charter that outlines its oversight responsibilities for internal control.
InVision's board members have sufficient expertise to oversee management's ability to design, implement and operate information security controls. The board engages third-party information security experts and consultants as needed.
InVision's board of directors meets at least annually and maintains formal meeting minutes. The board includes directors that are independent of InVision.
InVision management has established defined roles and responsibilities to oversee the design and implementation of information security controls.
InVision maintains an organizational chart that describes the organizational structure and reporting lines.
Roles and responsibilities for the design, development, implementation, operation, maintenance, and monitoring of information security controls are formally assigned in job descriptions and/or the Roles and Responsibilities policy.
InVision's information security policies and procedures are documented and reviewed at least annually.
InVision communicates system changes to authorized internal users.
InVision conducts access reviews at least quarterly for the in-scope system components to help ensure that access is restricted appropriately. Required changes are tracked to completion.
InVision ensures that user access to in-scope system components is based on job role and function or requires a documented access request form and manager approval prior to access being provisioned.
InVision tests their incident response plan at least annually.
InVision has security and privacy incident response policies and procedures that are documented and communicated to authorized users.
InVision's security and privacy incidents are logged, tracked, resolved, and communicated to affected or relevant parties by management according to InVision's security incident response policy and procedures.
InVision's security commitments are communicated to customers in Master Service Agreements (MSA) or Terms of Service (TOS).
InVision provides guidelines and technical support resources relating to system operations to customers.
InVision provides a description of its products and services to internal and external users.
InVision specifies its objectives to enable the identification and assessment of risk related to the objectives.
InVision's risk assessments are performed at least annually. As part of this process, threats and changes (environmental, regulatory, and technological) to service commitments are identified and the risks are formally assessed. The risk assessment includes a consideration of the potential for fraud and how fraud may impact the achievement of objectives.
InVision has a documented risk management program in place that includes guidance on the identification of potential threats, rating the significance of the risks associated with the identified threats, and mitigation strategies for those risks.
InVision has written agreements in place with vendors and related third-parties. These agreements include confidentiality and privacy commitments applicable to that entity.
InVision has a vendor management program in place. Components of this program include:
- critical third-party vendor inventory;
- vendor's security and privacy requirements; and
- review of critical third-party vendors at least annually.
Host-based vulnerability scans are performed at least quarterly on all external-facing systems. Critical and high vulnerabilities are tracked to remediation.
InVision notifies customers of critical system changes that may affect their processing.
InVision has an external-facing support system in place that allows users to report system information on failures, incidents, concerns, and other complaints to appropriate personnel.
InVision has established a formalized whistleblower policy, and an anonymous communication channel is in place for users to report potential issues or fraud concerns.
InVision maintains cybersecurity insurance to mitigate the financial impact of business disruptions.
HIPAA and the business associate agreement
When InVision processes PHI on behalf of a covered entity, it does so as a business associate under an executed business associate agreement. The BAA governs permitted uses and disclosures, the safeguards InVision applies, breach notification obligations, subcontractor flow-down, and the return or destruction of PHI at termination.
An on-premise deployment can change this analysis materially — if no PHI is disclosed to InVision, the relationship your counsel needs to paper may be different. We will work from your paper or ours.
Subprocessors
An on-premise deployment involves no InVision subprocessors in the PHI path — inference runs on your own host and no image data leaves it. For cloud deployments, InVision's infrastructure is hosted on Amazon Web Services in the United States. A current list of subprocessors that may process customer data, including purpose and country of processing, is provided as part of the security review package below, and customers are notified of changes under the terms of their agreement.
Vulnerability disclosure
InVision welcomes reports of suspected security vulnerabilities in its products and infrastructure from good-faith security researchers. Reports are triaged by our security team, and reporters receive acknowledgement and status updates through remediation.
Send reports to contact@invisionmedtech.com. Please include enough detail to reproduce the issue.
Please do not include protected health information in a report, and please do not access, modify, or exfiltrate data that is not yours.
Reports and documents
The documents a security review asks for, available to prospective and current customers under NDA. Request them through the form below.
Frequently asked questions
Does InVision have a SOC 2 Type II report?
Yes. InVision maintains an independent SOC 2 Type II attestation covering the security of the systems that process customer data, audited by Johanson LLP and backed by continuous control monitoring, annual penetration testing, and cybersecurity reviews. The report is available to prospective and current customers on request under NDA.
Is InVision HIPAA compliant, and will you sign a BAA?
Yes. When InVision processes protected health information on behalf of a covered entity, it does so as a business associate under an executed business associate agreement, with administrative, physical, and technical safeguards for PHI. We will work from your paper or ours.
Can InVision run on-premise so PHI never leaves our network?
Yes. On-premise, InVision runs inside your data center behind your firewall; all inference runs locally and no image data is retained after processing. A validated US cloud option is also available.
Where is customer data stored?
In the United States. On-premise, data stays in your own data center; in the validated cloud, it is hosted on AWS within your US region. There is no international processing of customer data.
How do we get the security review package?
Request it from the Trust & security page. The SOC 2 Type II report, subprocessor list, architecture and data-flow documentation, and our completed security questionnaire are available to prospective and current customers under NDA.
Request the security review package
SOC 2 Type II report, subprocessor list, architecture and data-flow documentation, and our completed security questionnaire — available to prospective and current customers under NDA.