LUND, SWEDEN – The company is pleased to announce that the Paindrainer® App has been certified by the Organization for the Review of Care and Health Apps (ORCHA). ORCHA is the world’s leading, independent digital health evaluation and distribution organization, providing verification and certification, which is trusted and accepted by health-care organizations internationally.
ORCHA’s assessment involves a detailed analysis looking across all the key areas of regulation and compliance. Mobile health apps are assessed against 350 criteria covering 3 main domains:
- Clinical assurance and safety
- Data and privacy
- Usability and accessibility
“ORCHA’s approval is yet another important confirmation and recognition of the quality of Paindrainer®. Clinical evidence, FDA registration approval as a Medical Device Class 1 and now ORCHA certification proves that Paindrainer® is an effective, safe and reliable tool fulfilling the highest quality standards. Consequently, healthcare providers can be completely confident to integrate Paindrainer® and we are convinced that Paindrainer® will change the lives of millions of people living with chronic pain.”, says Erik Frick, CEO Paindrainer AB.
Paindrainer® is with its excellent review score also included in ORCHA’s digital health app library, presenting healthcare providers with a standardized approach to determine the safety of digital health products, thereby promoting their effective integration into healthcare practices.
ORCHA works with governments and health systems and in collaboration with the American College of Physicians (ACP) and the American Telemedicine Association (ATA) the Digital Health Assessment Framework (DHAF) was created. As part of the ORCHA certification, Paindrainer PD1 2.1.2 is also now certified according DHAF confirming that Paindrainer PD1 meets US best practice and standards.
“The DHAF certification is another crucial milestone as we are preparing for commercial introduction in the US through healthcare providers. We are exceptionally proud of what we have achieved in a timely manner and are looking forward to this exciting and promising commercial phase of Paindrainer AB.”, concludes Erik Frick.
About Paindrainer AB
Paindrainer AB is a company developing digital platforms and applications contributing to health and well-being. Paindrainer was founded in 2018 by Prof. Carl Borrebaeck, Dr. Maria Rosén Klement, and Göran Barkfors. The idea was born when Maria, after participating in several pain rehabilitation programs, realized that the pain is affected by many more factors than the human brain can comprehend.
The Paindrainer® App coaches the users in managing their pain and planning their day not to exceed a certain pain level, and to ensure that there is enough energy left for highly valued activities. The solution is powered by leveraging advanced algorithms and is fully adaptive to each patient, a feature called 360o patient-centricity©.
The Paindrainer® App is the first evidence-based AI powered digital tool demonstrating improved quality of life in patients suffering from chronic pain.
The Paindrainer® App (Paindrainer PD1) is an FDA registered Medical Device Class 1 (510k exemption), MDR compliant and CE certified. www.paindrainer.com