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About us

Outcome Measurement for Medical Devices

Healthcare providers are increasingly shifting from product buying towards solution procurement to mitigate risks associated with the roll-out of innovative products.

Limitations of traditional clinical study data have accelerated the need for Real-World Data to demonstrate real-world impact and superior clinical value.

Heartbeat Medical provides an independent outcome measurement platform to enable partners to gather reliable evidence and rely on a transparent framework for outcome-based contracting.

Demonstrate clinical value rapidly and accelerate product usage

Our cost-effective infrastructure enables the continuous collection of high-quality Real-World Data to generate solid clinical evidence, meet regulatory requirements and enhance clinical practice in real-time.
  • Collect high-quality, analysis-ready RWD and registry data
  • Leverage our network of 200+ sites to kick start your data collection rapidly

A real-world platform for real-world data

Our heartbeat outcome measurement platform seamlessly integrates with hospital infrastructure and the day-to-day clinical workflows.

With data collected at the heart of the clinical practice, we provide you with treatment outcomes as they are truly experienced by patients.
  • Intuitive patient interface with built-in GDPR-compliant consent
  • Secure platform interoperable with major Electronic Health Record systems
OUR SOLUTION

Heartbeat.PROinsights

Rapidly generate real-world evidence of effectiveness with our modular infrastructure for continuous collection of real-world data.

Our RWE generation infrastructure bridges the gap between clinical trials and the real world. Get the right data at the right time while creating tangible value for hospitals and patients.

Scope

Our medical team will help you define suitable PRO endpoints and analysis methods to gain the insights you need.

Implementation

The management and implementation of your project is overseen by a central office that provides the highest level of supervision and support.

Site Network

We help you to select your project sites and support the implementation of their outcome data collection for a rapid start.

Measure Outcomes. Deliver Impact.

We work across a broad range of medical specialties, please contact us if you work in a different field and require further information.
Contact us

Oncology

Monitor quality of life and treatment effects to increase overall wellbeing.

Orthopedics

Evaluate treatment impact and monitor the recovery of patients with orthopedic conditions.

Mental Health

Improve mental health services quality by monitoring patients' quality of life and adjusting their treatments accordingly.

Spine Care

Evaluate treatment impact and monitor the recovery of patients with spine conditions.

Cardiology

Evaluate the impact of acute cardiac events on patients' quality of life and monitor the treatment of chronic conditions.

Other Areas

We work across a broad range of medical specialities.

Frequently asked questions

Need something that is not on this FAQ?

Our team will be happy to help, feel free to contact us directly.

What standards is heartbeat ONE compliant with?

Our digital platform heartbeat ONE is a class 1 CE-marked medical device under the Medical Devices Directive 93/42/EEC.

Where is the data stored?

Data can be stored locally (On-Premises) or on our dedicated servers (SaaS). For our SaaS solution, we currently work with two GDPR-compliant, certified data centers in Germany and Switzerland. Please inquire about additional hosting options in different locations.

  • Germany: the data center is ISO 9001 and ISO 27001 certified and additionally audited by TÜV Saarland.

  • Switzerland: the data center is ISO 5001 and ISO 27001 certified and additionally audited by Adsigo AG.

Who has access to the patient data?

Any identifiable patient data can only be accessed by designated individuals on the client’s side using a personal login and password. The patient data is stored securely; using 256 bit AES encryption.

For registries, clinical studies or further scientific evaluations an optional, separate consent needs to be provided by both the healthcare organization and the patient to share pseudonymized data with a third party including Heartbeat Medical. Our platform offers a GDPR compliant digital consent module for this purpose. 

Do I need a license to use the PROM questionnaires?

Some questionnaires may require a license or authorization from the developer to be implemented by your organization. Heartbeat can provide advice on cost-effective solutions and will support you obtaining the required authorization. The license holder is the client who is responsible for ensuring the payment of any license fee incurred.

When can I start collecting my PRO data?

Your data collection can start as early as 90 days after signing provided all information governance and IT authorizations are in place.

What languages does heartbeat ONE support?

Our interface supports multi-language implementation and is currently available in German, English and French. PRO questionnaires can be implemented in any language provided a validated translation exists. Please feel free to inquire about further language options.

What is the fee for heartbeat ONE?

Our pricing depends on several parameters and is a combination of fixed, one-off installation costs and an annual license. Please contact our team to discuss your project in more detail and obtain an accurate quote.