Remote Patient Monitoring
You have the device. The hard part is everything behind it. An RPM product needs device connectivity, somewhere to put clinical data, a portal clinicians will actually use, alerting that holds up under load, an EHR path, and a documentation trail your regulatory team can defend. None of that is your differentiation. BioT is the infrastructure layer underneath it.
Your device and your algorithm stay yours. The infrastructure underneath handles what every RPM product needs and none of what makes yours different.
Your device keeps its classification and its clearance. BioT sits underneath as infrastructure.
APIs and SDKs connect the device, the patient app and the clinician portal to one data layer.
EHR, analytics and algorithm integrations run through the same platform layer, inside the same audit scope. See how the EHR connection works.
Device readings, patient records and clinician actions land in one audited data layer, with access controlled per role.
See the submission documentationYour RPM product
The obligation
What BioT provides
The obligation
Intended use, clinical claim, the algorithm and the submission that covers them.
What BioT provides
HITRUST r2, SOC 2 Type II, ISO 27001, ISO 27799 and ISO 13485, for the platform layer.
The obligation
Your own IEC 62304 documentation, risk file and postmarket plan for your device software.
What BioT provides
Documentation you can reference for the infrastructure layer, reissued with every major release.
BioT customers have achieved FDA clearance and CE marking.
See the full table on the compliance pageThe BioT platform
The requirement
What the platform provides
The requirement
Devices have to connect, stay connected, and be managed once there are thousands of them in homes.
What the platform provides
Inventory, provisioning, access control, configuration and over-the-air firmware updates, across hardware devices, SaMD and AI-based devices.
The requirement
RPM data is patient data from the first reading. Access control bolted on above the database is the usual shortcut and the usual finding.
What the platform provides
Enforced where the data sits, with end-to-end encryption and a dedicated environment per customer.
The requirement
A clinician will not adopt a portal built for engineers, and alerting that misfires gets switched off.
What the platform provides
Role-based views for clinician, administrator and patient. Alert rules with no code templates, low code SQL, or your own code when the logic is yours.
The requirement
An RPM product that cannot reach the record creates work for the clinician instead of removing it.
What the platform provides
Through the EHR module or open APIs. Third-party algorithms connect the same way.
The requirement
The data is the asset, but running queries over patient data is where privacy controls usually break.
What the platform provides
Queries run with the privacy controls still enforced. Use the Developer Studio and SQL, or bring your own tools.
Platform certificates and documentation are available on request.
BioT runs in one of two models. Which one you choose determines where your data sits, and both give you a dedicated production environment.
Installed into your own AWS account, so the deployment and its data stay in your account.
Hosted on a BioT-managed account, with a dedicated environment for production.
Hosted on AWS, with availability in the US, EU and Asia.
A BAA and a DPA are available under both models.
BioT publishes the third-party subprocessors used to host and process customer data, with their location and the service each one performs. A BAA and a DPA are available under both deployment models.
See the subprocessor listBioT holds HITRUST r2 certification, SOC 2 Type II attestation, and ISO 27001, ISO 27799 and ISO 13485 certification. Software development follows IEC 62304. Every major release ships an updated Design History File and SBOM, roughly every two months. The document set is described at docs.biot-med.com and provided under NDA on request.
See the certification listNo. BioT is the infrastructure layer. The RPM product, its intended use and its clinical claim are yours.
As documented SOUP with a supplier Design History File behind it. BioT provides specifications, validation evidence, known-anomaly reporting and an SBOM, reissued with every major release, packaged so your file can reference them. Your device-level requirements, risk analysis and testing stay yours.
See the verification and validation documentationOn AWS, with availability in the US, EU and Asia. In the customer-account model the deployment sits in your own AWS account. In the managed model it runs on a BioT-managed account with a dedicated environment per customer.
Yes, in every deployment. Both ship in the compliance pack, along with current certificates. Ask through the contact page and the team will send everything.
2026 All rights reserved
Last updated on:
August 5th, 2026 VER .17