Orla INR Remote Monitoring

The effectiveness of the Orla INR Remote Monitoring service was assessed in a first Digi-HTA assessment in 2022, and the evaluation material gathered at that time will also be taken into account in this assessment. 

The benefits to be achieved through the product 

The Orla INR Remote Monitoring service enables the patient to conduct self-measurement and self-care. Health care professionals can shift the responsibility for measurement and treatment to the patient while retaining a full picture of the patient’s measurement results and medication decisions. The purpose of the service is to improve the patient’s management of their anticoagulation treatment. The treatment is considered to be in balance when the time in therapeutic range (TTR) is over 80%. [1] 

The service can be used in two ways:  

1. Self-measurement: Patients measure their own INR value, on the basis of which future dosage of medication is determined by the responsible professionals. The patient can view the dosage instructions in the mobile app. 2. Self-care: Patients measure their own INR value and determine their own dosage of medication. Health care personnel can observe the values and doses of medication (= remote monitoring).

Research evidence relating to the product under evaluation 

The aim of the Oulunkaari INR remote monitoring project was to improve the INR balance of patients receiving warfarin treatment and to evaluate the effectiveness of remote monitoring in primary health care. During the course of the project (1 May 2022 – 31 May 2023), 45 patients implemented a self-measurement regimen, measuring their INR values autonomously. A nurse determined the dosage and the next follow-up appointment. Seven patients implemented a self-care regimen by independently measuring the INR value and determining their own medication dosage. The nurse offered support if needed. All of the patients lived independently, and their age ranged from 37 to 92 years. [1] 

There were a total of 12 INR nurses using the Orla INR Remote Monitoring service, six of whom responded to the feedback questionnaire. In the spring 2023 feedback survey, the professionals’ recommendation index (NPS, Net Promoter Score) was +60. Respondents estimated that working hours spent on treating INR patients decreased by one half when patients were switched to remote monitoring. [1] 

In the patient feedback questionnaire, the NPS was +86. The questionnaire was sent to 50 patients, 41 of whom responded. Patients and their relatives were very complimentary of the savings in money and time achieved through self-monitoring and self-care. During the project, the treatment balance, i.e. TTR, of the patients improved overall. Prior to remote monitoring, patients had a median TTR of 71.7%, and at the end of the project the median TTR was 82%. [1] 

The service provider has carried out real-time monitoring of 58 patients in five different localities. Based on these results, the time in therapeutic range (TTR) was 70.71% before prior to the remote monitoring period and 75.72% towards the end of the remote monitoring period (the difference is not statistically significant). Prior to remote monitoring, 13 of the patients were at the target TTR level of > 80%, at the end of the period there were 29 patients at target level (difference statistically significant). [1] 

The results demonstrate that for some patients remote monitoring is suitable and their treatment balance improves, but on the other hand, there are patients for whom it is not appropriate and causes their treatment balance to deteriorate. According to the satisfaction questionnaire issued by the service provider, both patients and organisations have been satisfied with the service. [1] 

Literature reviews 

Systematic reviews of the subject have been published, indicating that self-measurement and self-care are at least as good as ordinary care [2,3,4,5].  

Dhippayom et al. (2024) published a systematic overview and a network meta-analysis comparing the four warfarin treatment modalities: standard care, anticoagulation management services, patient self-measurement and patient self-care. A total of 28 randomised controlled trials (RCT) encompassing a total of 8,100 patients treated with warfarin were included in the review.  

No statistically significant differences in overall mortality, incidence of major bleeding, strokes, or TIA seizures, or hospitalisation rates were observed between treatment modalities. The only treatment type that indicated a statistically significant reduction in relative risk (RR) of thromboembolic events was self-care. Compared to anticoagulation management services, the risk was reduced (RR = 0.42; 95% CI [0.18-0.99]), but the certainty of the evidence was low. Compared to standard treatment, the risk was similarly reduced (RR = 0.41; 95% CI [0.24-0.71]) with a moderate certainty of evidence. This effect was observed especially in studies with a follow-up of more than 12 months (RR = 0.41; 95% CI [0.23-0.72]) and in patients who had just started warfarin treatment (RR = 0.42; 95% CI [0.22-0.81]). 

The study also looked at the effects of treatment modalities on INR balance and found that self-care improved TTR by 7.39% on an average 95% CI [2.39-12.39] and self-measurement by 7.85% on an average 95% CI [1.82-13.88], as compared to standard treatment. However, the certainty of evidence in both of the above cases was assessed to be very low. [2] 

The Cochrane review looked at self-measurement and self-care as a unit. RR for thromboembolic events decreased compared to standard therapy (RR = 0.58; 95% CI [0.45-0.74]), but there were no differences in risk of major bleeding (RR = 0.95; 95% CI [0.80-1.12]) or mortality (RR = 0.85; 95% CI [0.71-1.01]). When considering self-care only, the risk decreased for thromboembolic events (RR = 0.47; 95% CI [0.31-0.70]) and mortality (RR = 0.55; 95% CI [0.36-0.84]), but there was no difference with regard to major bleeding. When considering self-measurement only, the risk of thromboembolic events (RR = 0.69; 95% CI [0.49-0.97]) decreased, but such a decrease was not observed for major bleeding or mortality. 16 studies reported INR values at the target level (tests in range). In 15 of these, results improved in the self-measurement or self-care groups. It should be noted that the quality of the evidence was not very good in any of the studies included. [3] 

With regard to all studies, it should be taken into account that self-measurement and self-care patients have taken INR measurements more often than those in ordinary care. In the studies, the interval has typically been 1 week and in real-time studies 2 weeks. In the standard treatment regimen, INR values are measured once a month. This more frequent measurement of INR may contribute to improved treatment balance.  

All of the studies note that self-measurement or self-care are not suitable options for all patients. Therefore, special attention should be paid to patient selection, and in the initial stages, the effectiveness of the treatment should be monitored closely. The remote monitoring services used in the examinations have varied, but all are based on the implementation of digital systems to facilitate communication between professionals and patients. 

Other observations from the studies  

Several follow-up studies covering real-time, actual use have been published, encompassing a larger group of patients and over a longer follow-up period. Of these, a Spanish study concluded that self-measurement and self-care are at least as effective as standard care. [6] A Danish register-based study compared self-care with direct oral anticoagulants (DOACs). The study demonstrated that self-care is safe and effective for properly trained patients. Patients undergoing self-care have a lower risk of stroke than patients undergoing DOAC treatment. There were no differences in the risk of major bleeding or mortality. [7] 

Other recommendations and assessments  

The National Institute for Health and care Excellence (NICE) conducted an assessment on self-measurement and self-care in the United Kingdom in 2014 [8]. In 2021, Canada’s CADTH (Canadian Agency for Drugs and technologies in Health) examined the experiences of patients and relatives [9]. In 2015, Swedish researchers examined the cost-effectiveness of self-measurement and self-care [10]. 

A risk analysis has been drawn up for the product, which will be regularly updated as part of the company’s risk management plan. The risk management plan defines the processes and notification practices that ensure the safety of the product. The design of the product has identified possible safety risks and attempted to minimise them. The incorrect use of the product is to be prevented through user instructions. [1] 

The company has a designated person responsible for the safety of the product. According to information received from the company, the product has not caused any safety incidents or other anomalies impacting the safety of the customers. [1] 

The costs are determined by the number of clients. The use of the product is subject to a fixed monthly maintenance fee per organisation as well as a monthly fee per patient. [1] 

The introduction of the product requires alterations to existing treatment processes. Deployment will incur costs depending on the time required to undertake staff training and changes to the treatment process. If the customer organisation acquires ownership of the measuring devices, this will incur additional costs. No separate fee will be charged for user training. [1] 

The fixed monthly maintenance charge per organisation includes costs related to [1]  

• automatic updates 

• development 

• maintenance 

• data collection 

• device renewal. 

An impact-based agreement or a fixed-price agreement may be concluded on the monthly fee per patient [1].  

The fixed monthly fee per patient includes the right to the use of the service and, depending on the agreement, measuring device and other equipment. A monthly lease will be charged for the use of the measuring devices, unless the client has purchased them. The patient may acquire additional measurement equipment and agree on their costs with the health care service provider. [1] 

In an impact-based agreement, the monthly fee per patient depends on the patient’s response to treatment. The agreement includes a trial period (4 +2 months), during which the benefit of the use of the product will be assessed. [1] 

The costs incurred by the patient in using the product are determined by the client organisation purchasing the product [1].  

Based on the information provided by the company, the costs of using the service appear to be reasonable compared to providing the corresponding service in some other way. 

The assessment was carried out using the list of data security and data protection requirements for social welfare and health care procurement and the response material provided by Orla DTx [1]. 

Risk management and data security testing 

The manufacturer has processes to: 

• manage security incidents and conduct threat modelling for comprehensive data security risk management 

• carry out data secure software development, as well as include the testing of data security features are in their software testing process 

• manage data security risks within third party software 

• The company has appointed officers responsible for security incidents.  

Log management 

Log data is gathered from the software operations and is actively monitored. A tracking log of the patient data access by the professionals is also available. 

User management 

The service makes use of role-based management of licensing. The service does not support multi-step authentication, instead, IP address filtering is enabled to limit access. Single sign-on (SSO) is available with an additional fee and includes support for smart card identification. 

Hardware 

The monitoring device (Roche Diagnostics CoaguChek® INRange) uploads the measurement results through the Orla INR smartphone app and a Bluetooth Low Energy (BLE) connection. The monitoring device is not included in this assessment. The data connection between the smartphone and the service is encrypted. 

Data protection 

Patient personal data will be stored in Finland. Other data pertaining to client relationships will be stored within the EEA in accordance with the GDPR. The data is protected at rest and the encryption algorithms and data security processes are in accordance with best practices. 

The product has been subject to a data protection impact assessment (DPIA). 

The company acts as the data processor and the client organisation acts as the controller. 

Other considerations 

The service is only available under a Software as a Service (SaaS) distribution model. 

This assessment does not include interfaces with external services. If the client organization deploys integrations, such interfaces need to be assessed separately. 

General guidance on procurement  

During the purchase phase it is always important to contact the IT management, data security specialist and data protection specialist of the organisation. Please discuss with them whether the product in question fulfils your requirements. In addition, we recommend that wellbeing services counties utilise the European Union Agency for Cybersecurity’s (ENISA) data security procurement guidelines [12]. 

The Roche Diagnostics CoaguChek® INRange monitoring device is not covered by this usability and accessibility assessment.  

• The service provides separate user interfaces for professionals and clients. The client mobile app is available for the iOS (9.0 or later) and Android (8.0 or later) operating systems. Both versions have been implemented in accordance with each platform’s specific design guidelines.  

• For professionals, the service is available as a website. The professional application supports modern web browsers. [1] 

Usability 

The usability of the product has been evaluated through surveys with health care professionals and clients, and the client participants correspond to actual end-users. The language and design of the application’s text content have been designed on the basis of company guidelines in cooperation with professionals in the field and user interface experts. According to the company, both the functionality of the text content and its comprehensibility have been tested both on trial subjects and on clients. [1] 

Accessibility 

An accessibility assessment has been conducted for the client application, carried out by an external party. The product meets the technical accessibility requirements as defined by European standard EN 301 549. The accessibility status is described in the accessibility statement of the product, available on the company’s website. [15]  

Ease of use features supported by platforms are not excluded [1]. 

Instructions for use for patients are accessible [1]. 

The website intended for professional use is not covered by accessibility requirements, but the accessibility considerations have been taken into account for different user groups as follows: [1,15]. 

• Visually impaired and partially sighted persons: Supports magnification.  

• Abnormal colour vision: Status symbols are designed to also stand out by visual means other than colours  

• Poor Finnish skills and/or dyslexia: Clear and brief text. 

• Fine motor issues: Option for keyboard navigation.  

The following user groups have not been considered in the professional user interface: 

• Persons with severe visual impairments: Screen reader is not supported. 

Feedback on the accessibility of the product can be provided by email or telephone. According to the company, it will respond to the feedback within 14 days. [1,15] 

General guidance on procurement  

The purchasing organisation shall take into account the accessibility requirements set out in the legislation in force at the time [16]. 

Interoperability 

The Roche Diagnostics CoaguChek® INRange monitoring device is connected to the Orla Remote Monitoring application via a Bluetooth LE version 4.0 connection. The system stores data in a structured form and allows them to be exported to other systems through the FHIR API or other interfaces. [1] 

For the time being, the service will not be integrated with other software or services.  

The product supports single sign-on integration (SSO) [1]. 

Technical functionality 

According to the manufacturer, there have been no outages in the service, and the service has not been disabled due to a failure in the last six months. The service is updated on a regular basis 2-4 times a year. These updates take place outside official hours and cause only brief interruptions in the services for professionals. [1] 

The product needs a wireless connection (cellular network connection or Wi-Fi) to function. In addition, Bluetooth is used for communication between the INR device and the mobile app. The mobile app for clients is designed to work offline as well, so system updates will not affect its performance. [1] 

The manufacturer shall notify the contact persons of the user organisations in advance of any product updates and potential downtime. If necessary, health care professionals will ensure client communication. [1] 

Training and product support 

The company offers product support via email and phone in Finnish, Swedish and English. The service provider provides training to the personnel of the organisation. The organisation must train patients for the use of the service. The company has a project plan ready to help support the introduction of the product. [1] 

Product distribution 

The product is used in five wellbeing services counties and through those in 20 health care centres. [1] 

1. The Digi-HTA questionnaire filled out by the company, not public information. 
2. Dhippayom, Teerapon et al 2024. Comparative effectiveness of warfarin management strategies: a systematic review and network meta-analysis. eClinicalMedicine, Volume 74, 102712. DOI: 10.1016/j.eclinm.2024.102712 
3. Heneghan CJ et al 2016. Self-monitoring and self-management of oral anticoagulation. Cochrane database of Systematic reviews 2016, Issue 7. Art.No.: CD003839. DOI: 10.1002/14651858.CD003839.pub3  
4. Sharma T et al 2015. The clinical effectiveness and cost-effectiveness of point-of-care tests (CoaguChek system, INRatio2 PT/INR monitor and ProTime Microcoagulation system) for the self-monitoring of the coagulation status of people receiving long-term vitamin K antagonist therapy, compared with standard UK practice: systematic review and economic evaluation. Health Technol Assess 2015;19(48). DOI: 10.3310/hta19480 
5. Dhippayom T el al 2021. Clinical Outcomes of Different Warfarin Self-care Strategies: A Systematic Reviews and Network Meta-Analysis. Thropmb Haemost 2021. DOI: 10.1055/a-1677-9608 
6. Menéndez-Jándula B. et al 2019. Long term effectiveness and safety of self-management of oral anticoagulants in real-world settings. BMC Cardiovasculasr Disorders 2019; 19:186. DOI: 10.1186/s12872-019-1168-2 
7. Grove E. Effectiveness and safety of self-managed oral anticoagulant therapy compared with direct oral anticoagulants in patients with atrial fibrillation. Scientific reports 2018;8:15805. DOI: 10.1038/s41598-018-33531-7 
8. NICE Guidance. Atrial fibrillation and heart valve disease: self-monitoring coagulation status using point-of-care coagulometers (the CoaguChek OX system). Diagnostic guidance [DG14]. Published 24 September 2014, last updated: 19 December 2017. 
9. CADTH Health Technology Review. Point-of-care Testing of Internetional Normalized Ratios for People on Oral Anticoagulants: A Rapid Qualitative Review. Canadian Journal of Health Technologies, March 2021, Vol.1, Issue 3. 
10. Hälsoekomomisk utvärfering gällande självmonitorering vid behandling med warfarin, 2015. Tandvårds- och läkemedelsförmänsverket. 
11. National Cyber Security Centre: Information security and data protection requirements for social welfare and healthcare procurements. Available at: https://www.kyberturvallisuuskeskus.fi/en/ncsc-news/instructions-and-guides/information-security-and-data-protection-requirements-social Accessed on 25.2.2025 
12. The European Union Agency for Cybersecurity Procurement Guidelines for Cybersecurity in Hospitals. Available at: https://www.enisa.europa.eu/publications/good-practices-for-the-security-of-healthcare-services. Accessed on 29.4.2025 
13. Act on the Provision of Digital Services 306/2019 (Available only in Finnish). Available at: https://www.finlex.fi/fi/laki/alkup/2019/20190306. Accessed on 17.4.2025 
14. Requirements of the Act on the provision of Digital Services. Available at: https://saavutettavuusvaatimukset.fi/fi/digipalvelulain-vaatimukset/digipalvelulain-vaatimukset-toimijoille.Accessed on 17.4.2025 
15. Orla accessibility statement. Available at: https://orladtx.com/fi/saavutettavuusseloste-inr/ 
16. Laki julkisista hankinnoista ja käyttöoikeussopimuksista 1397/2016 Available at: https://www.finlex.fi/fi/laki/alkup/2016/20161397. Accesed on 17.4.2025 

Jari Haverinen, erikoissuunnittelija, FinCCHTA 

Raija Järvinen, erikoissuunnittelija, FinCCHTA 

Teemu Mustola, erikoissuunnittelija, FinCCHTA 

Tommi Hanhela, tietoturva-asiantuntija, Oulun yliopisto 

Jere Kinnunen, tietoturva-asiantuntija, Oulun yliopisto 

Antti Koskela, tietoturva-asiantuntija, Oulun yliopisto