The co-operation between Orla DTx Oy and Roche Diagnostics Oy takes patients to a new level of self-care in Finland. Orla INR Remote Monitoring, a service that includes the Roche Diagnostics CoaguChek® INRange measuring instrument, and the Orla Remote Measurement mobile application, enables patients a new level of self-care. When using the Roche Diagnostics CoaguChek® INRange measuring instrument as well as the Orla Remote Measurement mobile application, patients are able to perform INR measurement from the comfort of their own home, while still having direct contact to the health care professionals.

The Orla INR Remote Monitoring has recently received the Digi-HTA recommendation with a maximum score (10/10) in the assessment of the Finnish Coordination Centre for Health Technology Assessment (FinCCHTA). It is becoming an evermore established process to issue recommendations for digital health solutions available on the market. As the recommendation gives health care professionals and decision makers a reliable and impartial assessment of different digital health products, the procurement decisions of healthcare organizations can be simplified. The assessment looks into the effectiveness, safety, costs, security and data protection, as well as the usability and accessibility of the service.

Read more about the co-operation between Orla DTx Oy and Roche Diagnostics Oy, and the Digi-HTA recommendation here (the English text is found below the Finnish text).

5.6.2023

The servers of Orla Etämittaus will be updated on Monday June 19th between 17:00 and 22:00. Patients can use the service like normal; the mobile application will send the data collected during the update when the connection to the servers has been established again.

19.4.2023

This update improves the service’s device support:

  • Improvements related to the PEF device support:
    Support for the Medikro Duo measuring device has been added to the mobile application. This does not cause any changes in the use of the application; the app is used the same way with both Medikro and Vitalograph measuring devices.
    You can ask Orla for more information about the measuring device and its support.

The update does not require any action from users or patients.

4.5.2022

This update improves the usability and device support of the mobile application for remote PEF measurements:

  • Improved the operation of PEF remote measurements of symptom measurements
  • Added support for the new Vitalograph measuring device model (the change is technical and is concerned with wireless data transmission, the new measuring devices are not externally different from the old ones)

The update does not require any action from users or patients.

20.12.2021

This update improves the usability and accessibility of the mobile application:

  • Added support for screen readers (iOS VoiceOver and Android TalkBack)
  • Added support for Bluetooth keyboards and keyboards navigation

The changes cause minor changes in the appearance of the application, for example, the selection buttons now look a little different, but the application is used in the same way as before.

The update does not require any action from users or patients.

24.3.2021

The updated version of the remote monitoring mobile application has now been released. The name of Elisa Remote Monitoring (Elisa Etämittaus) changes to Orla Remote Monitoring (Orla Etämittaus) and the application icon changes. The application works as before, and you can continue to use it as normal.

Links to app stores can be found on our website: https://orladtx.com/fi/potilasohjeet/

Please note that the official name of the mobile application was changed to Orla Etämittaus, and therefore in the future when searching for the Etämittaus application in the app store, you should use “Orla Etämittaus” as the search term. This update does not bring any other changes to the service itself and does not require any other actions from our customers.

A major challenge in primary healthcare 

Primary healthcare is in crisis all over the world. A large part of healthcare services is mass-produced and very often created with a focus on healthcare instead of patients’ needs. The treatment of patients is insufficient, i.e., the treatment does not follow the national Current Care Guidelines. Patients are treated on a calendar basis (e.g., annual visits) and the healthcare service has no information about the patients’ quality of care between visits. Currently, patients who do not need treatment burden the healthcare system, and patients who do need treatment do not have timely access to care due to limited healthcare resources.  

Healthcare is unsustainable in many respects because the costs of treatment have become prohibitive and the achievable health benefits have run into diminishing returns. This causes a great burden in healthcare, especially for nurses, who are heavily under-resourced and under pressure, as the shortage of nurses worsens year by year due to the Western demographic structure. 

Sustainable renewal of healthcare 

The sustainable renewal of healthcare requires building a common vision of how we want our healthcare to function in 2030 and what the role digitalization has in the realization of the vision. Before creating a vision, it is important to form a situational picture of Finnish healthcare and its wellbeing services county specific 1) structural and functional capabilities, 2) existing and required resources for providing health services, 3) management models and systematic measurement of results, and 4) the way digital infrastructure and services work as part of the system. 

Digitalization is one of the most important opportunities to increase the productivity and cost-effectiveness of healthcare. The transformation of healthcare is progressing, and Finland is doing well in international comparisons, although behind the leading countries. The structural reform of Finnish healthcare gives us a good opportunity to redeem the productivity promises of digitalization. If the reform fails to utilize digitalization towards sustainable healthcare now, we will have to pay the price later – when it will be more difficult, slower, and more expensive. 

Impactful digitalization of healthcare requires a comprehensive approach and implementation of value-based services to care pathways 

We lose a great opportunity to transform healthcare if all stakeholders don’t have a shared vision about the role in digitalization and they are not actively involved in transition towards impactful and sustainable care. The journey towards the full use of digitalization requires a comprehensive strategic level approach, which considers 1) coordinating interplay of existing care practices and new service models 2) the formation of a work culture that supports renewing operations and 3) the development of a digital infrastructure that enables operations and serves future needs. By doing this, we can create a sustainable entity that supports the day-to-day activities of healthcare, where the central part is effective and automated digital services for improvement of care, care management, and logistics. 

We at Orla believe that impactful digital solutions are the most effective way to promote the effectiveness of primary healthcare in the future. To increase awareness of this important theme, we produced the ‘Effectiveness-based healthcare 2023’ webinar series in a collaboration with Roche Finland and Orla DTx during the spring. The last part of the webinar series ‘Pilots promoting the health impact of wellbeing services counties’ brought together a wide group of healthcare professionals, and in total we brought together more than three hundred professionals. 

Jaana Ahlamaa (medical director, LM, MD) from Ahlamaa Consulting was the host and introduced the webinar. Ahlamaa highlighted what is required from the point of view of social effectiveness in evaluating services and development projects that are to be procured and put into use on a large scale. Here are the essentials from the brilliant introduction: 

  • When properly implemented, the benefits of digitization for healthcare are remarkable: they promote access to care and the availability of treatment, the implementation of needs-based healthcare, data-driven management and remote monitoring, free up the capacity of the service system and guide the allocation of the resources used, and improve commitment to treatment and patient self-management. 
  • Impact in the context of healthcare is evaluated by comparing the benefits of the service with, for example, existing treatment practice, no treatment or preventative care. 
  • When evaluating cost effectiveness, the costs with which the effects are achieved and the ratio of additional costs to the achieved benefit are considered. Particularly important is the real-world impact of the service – how it helps patients and healthcare professionals in their daily routines and activities. 
  • Evaluation of a real-world impact of digital solutions requires reliable measurement methods. For example, the patient’s perceptions of health and wellbeing may differ. With the help of digital solutions, measuring real-world impact and collecting customer experience becomes easier and renews care practices. It includes all collected and accumulated health and well-being structured data produced by patients (PROMs and remote monitoring measurements) and healthcare systems (lab, imaging etc.). 

Orla DTx and Buddy Healthcare modernizing healthcare 

We heard about the benefits of effective digital solutions from two wellbeing services counties and a pioneering company. 

Buddy Healthcare and Satakunta wellbeing services county explained how the automation of care management can make care work more efficient and improve the customer experience. 

Orla DTx and the Northern Ostrobothnia wellbeing services county Pohde described how digitally supported patient self-management for patients with atrial fibrillation improves treatment results. The work is part of Sitra’s digital therapeutics pilots, which explore the benefits of digital services to achieve better treatment results with proven cost benefits. 

Here are the videos of a brief summary of the webinar (in Finnish) (Orla’s LinkedIn) and the entire webinar (in Finnish) from Roche’s website

During the second webinar of the three-part webinar series, a panel of influencers was organized with the topic The sustainable future of health – are digital solutions the way to a sustainable future? The panel of influencers brought together more than a hundred healthcare professionals. The panel which was led by Jari Numminen (pictured left) and included Katja Rääpysjärvi (North Ostrobothnia wellbeing services county Pohde, population 416.000), Mika Perttu (South Savo wellbeing services county Eloisa, population 133.000) and Annette Kainu (Medzilla Oy) had an insightful discussion about current changes in healthcare. 

The value-based healthcare 2023 webinar series continued with a panel of healthcare influencers

Value-based-based healthcare is beginning to be seen in need-based prioritization of patient care. However, the role of digitization in increasing the overall impact of healthcare requires a change in the prevailing way of thinking. Digital services should not be an afterthought or an additional burden on top of the workload, they should be an enabler of effective and sustainable healthcare. 

Digitalization, when implemented correctly, transforms healthcare to patient-driven care and serves patients in a need-based manner 

Digital services change the way care is delivered – the same information is visible to the professional and the patient. The patients’ personal motivation to take responsibility for their own health takes centre stage. 

Transition from the traditional hierarchical and healthcare centric model to patient driven healthcare is inevitable. By using digital services that collect relevant information about  patients (remote monitoring, patient reported outcome measures etc.)  both patients and healthcare professionals are guided in real time to make decisions that lead to balanced and well-controlled care. This enable enables early need-based interventions. As the role of the patients grows so does the need for remote support – this requires changes to care pathway designs that produce sustainable impact and have clear metrics. 
 
The role of professionals is crucial in implementation of new care pathway solutions. Professionals must have the necessary resources, training, and support to deploy new services in daily care practices. It is important to increase the patient’s knowledge and understanding that the services enable better care of their own health, starting from the very first patient encounter. After the patient’s onboarding digital services enable constant access to care and need-based interventions. 

Value-based services promote the evaluation and development of healthcare quality 

Digital services with proven impact produce reliable information about patients’ quality of care between visits as well as enable better management of care of entire patient population. The information produced by the services is versatile and information can be widely obtained, such as adherence medication, indication specific measurable variables (blood pressure, lung functions, blood values, etc.), symptom monitoring and structural surveys that map the state of the disease. Also feedback on customer satisfaction can be monitored. 

The structured production of information that supports the treatment plan, if implemented correctly, improves treatment results – clients can be treated as they should be treated, i.e., according to current care guidelines and prioritizing care. Reliable health status of patients supports the information-based management and forecasting of health prioritization in individual and population level. In this case, the impact and quality of health services can be monitored based on metrics. 

As the use of impactful digital services becomes more common, it enables continuous improvement of care quality and monitoring of quality at various levels of healthcare: on treatment pathway, care unit, wellbeing services county and national level. To improve the quality of care sustainably and to obtain solutions that solve health challenges for large populations we must monitor the quality of care systematically and have clear criteria and measures to monitor results on a national level. Part of this process is sharing the achieved results and challenges between wellbeing services counties. 

The sustainable improvement of healthcare requires a widespread use of digital services that have been proven to be effective

National guidance should consider effectiveness as the most important criterion in the acquisition of services that support healthcare and their development, because only effective services can promote the construction of sustainable healthcare. 

In Finland, this activity is supported by FinCCHTA’s Digi-HTA evaluation activity (Health Technology Assessment, HTA), which evaluates healthcare methods for all new digital health and well-being products. In the Digi-HTA assessment, the best available information is combined to support health policy and clinical decision-making, i.e., the assessment helps wellbeing services counties in the procurement of services. 

The five key areas of the evaluation provide information on how well the service supports effectiveness criteria and sustainable healthcare: 

  • Costs 
  • Effectiveness 
  • Safety 
  • Data protection and security 
  • Usability and accessibility 

Effective services produce increased health in a cost-effective, safe, and easily accessible way, and thus contribute to the sustainable renewal of healthcare – healthcare customers, healthcare professionals and society all benefit from this.

The webinar series organized by Roche Finland and Orla DTx focuses on the most significant administrative reform of Finnish healthcare, where the main goal is the promotion of sustainable healthcare, facilitating access to treatment and ensuring continuity of treatment. 

In the first webinar, ‘Effectiveness-based healthcare – towards the sustainable operation of wellbeing services counties’, we heard excellent presentations by Ville-Veikko Ahonen from the Ministry of Finance, Tuomas Nikoskinen from NHG and Jari Haverinen from FinCCHTA. Tuomas Mäkynen from Orla DTx was the studio host. 

You can watch the video of the webinar on Roche Finland’s website (in Finnish). 

The main messages during the energizing morning were: 

  • In the health and social services reform, a unified operating culture is especially important, which creates the basis for all activities. Currently, the focus is on stabilizing basic operations and strategic work to unify and renew service networks. 
  • Transitioning to effective digital solutions will help with the national healthcare personnel shortage, enable needs-based treatment, and promote the sustainability of the public finances – this cannot be achieved with old models. The productivity potential of renewing service networks is enormous, and it requires the commitment of the entire country and the wellbeing services counties. 
  • Understanding the chain of command is important to achieve the desired results, i.e., good services for customers. When choosing service networks, you must know how to make choices that sustainably support healthcare – for example, using effectiveness as a key criterion for service procurement. 
  • In Finland, Digi-HTA (Health Technology Assessment, HTA) is in use, which evaluates healthcare methods for all new digital health and wellbeing products. 
  • In the Digi-HTA assessment, the best available information is combined to support health policy and clinical decision-making, i.e., the assessment helps welfare areas in the procurement of services. The five key areas of the evaluation provide information on how well the service supports effectiveness criteria and sustainable healthcare. 
    1) Effectiveness 
    2) Cost 
    3) Safety 
    4) Data protection and security 
    5) Usability and accessibility 

The treatment of patients using blood thinners is enhanced in the Oulunkaari municipal association with Orla’s service.

The project started in May and the goal is to bring all warfarin-using patients in Oulunkaari who benefit from the service into supported patient self-management. In patient self-management, patients measure the INR value themselves and the measurement results are automatically transferred to healthcare professionals. The information transferred to healthcare professionals ensures accurate monitoring of patients, which in turn enables early intervention if necessary. The service also saves the nursing staff valuable time.

Sitra’s pilot project promotes the wider use of digital treatments and thus contributes to the transition of wellbeing services counties towards sustainable healthcare. Our service, recommended by FinCCHTA, supports warfarin treatment in several wellbeing services counties in addition to Oulunkaari municipal association.

Read more in Sitra’s bulletin (sitra.fi).

We are proud of the excellent work done by the Oulunkaari team, and the pilot project made possible by Sitra and the visibility it has received:

Oulunkaari’s healthcare services have already had such good experiences with remote INR monitoring of warfarin treatment that they wanted to join Sitra’s project.

Read more in Oulunkaari’s bulletin (in Finnish) (oulunkaari.com).

“When I measure INR at home and decide the medicine dose, I can easily monitor the effect of dietary changes on the treatment,” says Jarmo Piippo, who lives in Vaala.

”With the help of the application, we are now also able to deal with possible deviations in the value of the INR quickly,” says department manager Rekinen. ”Especially those who work on the road have praised the application. It has also made life easier for people vacationing abroad,” continues Rekinen.

https://www.mediuutiset.fi/uutiset/digiterapia-saastaa-resursseja-oulunkaaressa-uskon-etta-etamittaus-yleistyy-ja-laajenee-suomen-terveydenhuollossa/4908c6f0-8699-4744-896d-9ac662e7d097 (in Finnish)

At Sitra’s initiative, six pilot projects related to digital treatments are currently underway in Finland, focusing on the treatment of various diseases and syndromes and rehabilitation. One of these projects belongs to our customer, the wellbeing services county of North Ostrobothnia, Pohde (with population of 416 000), where the treatment of anticoagulation patients is enhanced with Orla’s service. Sitra’s goal is to promote the introduction of effective digital treatment solutions in Finland and to collect experiences from healthcare professionals and patients. 

Sitra is promoting the establishment of a national model for allowing digital treatment solutions to be approved for use and reimbursed in the same way as prescription medicines. In addition to patient equality and better treatment, this would make Finland an increasingly attractive environment for digital health companies and generate new business. Instead of the current fragmented market, a national model would unify requirements, enable procurement and provide clarity for both companies and buyers. Read more in Sitra’s bulletin (sitra.fi). 

At Orla, we believe that digital forms of treatment play a vital role in the transition to value-based healthcare (VBHC), and we support the establishment of a national model. The six-step model described by Sitra creates a good starting point for developing a sustainable operating model for Finland, which combines the best practices, learnings and experiences of countries that have already implemented their models (Germany, Great Britain, USA, Belgium, and France). Download the template from Sitra’s website (in Finnish) (sitra.fi). 

Sitran kuva
In the first step of the tiered model, a national level assessment process is implemented, and in the next step, the reimbursement of digital therapies. Photo: Sitra 

The ”FinCCHTA and Digi-HTA assessment in practice”- webinar organized by Sailab – MedTech Finland 1.9.2022 focused on national HTA development. HTA refers to the systematic assessment of healthcare methods, and the national HTA coordination unit FinCCHTA is responsible for their development in Finland. Orla’s experiences with the Digi-HTA assessment process were also presented. The event aroused a lot of interest and active discussion from the participants. 

Read more about the summary of the event published on Sailab – MedTech Finland ry’s website here (in Finnish). 

Orla INR remote monitoring

– The patient takes the INR measurement using the Roche Diagnostics CoaguChek® INRange measuring device, which is connected via Bluetooth to the Orla Etämittaus mobile application.

– The patient’s mobile application has an electronic warfarin card, and it reminds the patient of the measurements to be performed and informs about changes made by a healthcare professional to the warfarin dose. 

– The patient’s measurement data can be seen and used by healthcare professionals via the cloud service.

The product includes a mobile application intended for patients and a web-based service intended for healthcare professionals.

Orla INR

  • Enables better quality of care (TTR-%) for patients 
  • A direct view of patient compliance and outcomes 

Patient

  • Quality assured remote monitoring and patient self-management 
  • The opportunity to influence your own health and monitor your own quality of care

Healthcare professional

  • View of patient quality of care (24/7) 
  • Data-driven management of care is enhanced 
  • Care work prioritization and remote care are made possible 
  • Management of the patient population becomes more efficient 

The assessment of treatment technologies (Health Technology Assessment) serves healthcare broadly: It studies the conditions for the development, scaling up and use of methods as well as the health, social, ethical, and economic effects in a multidisciplinary manner. Reliable information about the short- and long-term effects of the methods is the basis for clinical and political decisions in healthcare. Evaluation of treatment methods is one of the many techniques of evidence-based healthcare. In different countries, healthcare methods are evaluated with different emphasis, but the methods and often also the evaluation questions are similar (HTA guide (in Finnish). Version 1.1. Helsinki: Suomalainen Lääkäriseura Duodecim; 2017).

10/10 in Digi-HTA assessment as the first service in Finland

As the first service in Finland, Orla INR remote monitoring has received the best possible usage recommendation from the Digi-HTA assessment conducted by FinCCHTA (Finnish Coordinating Center for Health Technology Assessment).

FinCCHTA’s assessment states that use of the product is recommended. The Orla INR remote monitoring service is suitable for patient self-testing (PST) or patient self-management (PSM) for patients receiving warfarin therapy. There is compelling evidence of the effectiveness of the service and the costs associated with its use are reasonable.

Read more about Orla’s INR remote monitoring service.

The Digi-HTA recommendation is a reliable and unbiased assessment of the suitability of the company’s product for anticoagulation treatment.
Healthcare representatives can use the Digi-HTA recommendation as support for decision-making and as a requirement in connection with procurement, when doing market mapping, or when starting to pilot services.

Orla INR remote monitoring

– The patient takes the INR measurement using the Roche Diagnostics CoaguChek® INRange measuring device, which is connected via Bluetooth to the Orla Etämittaus mobile application.

– The patient’s mobile application has an electronic warfarin card, and it reminds the patient of the measurements to be performed and informs about changes made by a healthcare professional to the warfarin dose.

– The patient’s measurement data can be seen and used by professionals via the cloud service.

The product includes a mobile application intended for patients and a web-based service intended for healthcare professionals.

Orla INR

  • Enables better quality of care (TTR-%) for patients
  • A direct view of patient compliance and outcomes

Patient

  • Quality assured remote monitoring and patient self-management
  • The opportunity to influence your own health and follow your own quality of care

Healthcare professional

  • View of patient quality of care (24/7)
  • Data-driven management of care is enhanced
  • Care work prioritization and remote care are made possible
  • Management of the patient population becomes more efficient

The Digi-HTA assessment promotes the procurement of effectiveness-based services

Digi-HTA is a recommendation that allows healthcare providers to get a reliable and unbiased assessment of the suitability of a company’s product to support decision-making. Healthcare provider representatives can use the Digi-HTA recommendation as a requirement when buying the service or when piloting services. The recommendation process is becoming established as a national function for digital solutions within healthcare. The Digi-HTA criteria and evaluation process is suitable for the evaluation of digital medical devices in healthcare and well-being, as well as digital non-medical devices or solutions, and it implements internationally accepted practices.

The assessment of treatment methods provides a basis for decision-making

The assessment of treatment technologies (Health Technology Assessment) serves healthcare broadly: It studies the conditions for the development, scaling up and use of methods as well as the health, social, ethical, and economic effects in a multidisciplinary manner. Reliable information about the short- and long-term effects of the methods is the basis for clinical and political decisions in healthcare. Evaluation of treatment methods is one of the many techniques of evidence-based healthcare. In different countries, healthcare methods are evaluated with different emphasis, but the methods and often also the evaluation questions are similar (HTA guide. Version 1.1. Helsinki: Suomalainen Lääkäriseura Duodecim; 2017).

Effective remote monitoring that works in practice

The Digi-HTA assessment provides information of the five areas to be evaluated (costs, effectiveness, safety, data protection and security, and usability and accessibility) and additionally of all key issues that must be considered when introducing the product, such as the required maintenance process and IT changes, integration with other healthcare systems, product support and training. The management of all these areas ensures the effectiveness of the service in the customer’s operating environment for patients, professionals, and the purchasing organization.

We ensure effectiveness in the customer’s operating environment – ​​for patients, professionals, and the purchasing organization.

Effective remote monitoring:

1) Clinical evidence of better treatment results and produces measurable resource savings.

2) Health-economic evidence of cost-effectiveness and falls within the scope of effectiveness-based procurement, i.e., only the results achieved are paid for.

3) Enables efficient and inclusive implementation.

4) Fits the digital strategy and architecture, enabling smooth integration and the use of measurement data between systems to support holistic care of the patient.

All kinds of stories concerning healthcare digitalization have been flooding from every outlet for most of the past decade. No wonder then, that sometimes both buyers and users are lost. However, we all can probably agree that digital health care solutions should not be procured without proper understanding of the costs in relation to the outcomes, i.e. one should always demand solid proof of effectiveness.

Like any drug, the effectiveness of digital health care solutions should be proven; it needs to improve treatment outcomes or save on costs, or both. At its best, it improves the functionality and availability of services and reduces the burden on health care.

A functional digital health care solution improves treatment results

The goal of a digital health care solution is usually to streamline or enhance treatment pathways; when the path is smoother and more effective, the patient receives better care and health care resources are allocated more rationally. For example, the patient may perform PEF or INR monitoring remotely, and the information is automatically transferred to his or her own caregiver. The patient receives immediate feedback if needed. No ambiguous records, no trips to the lab, less staff input – in short, better care and better treatment outcomes at a lower cost.

What is sufficient evidence of functionality?

In the past, digital treatment options could be marketed without any clinical evidence. Fortunately, the situation is partly changing with the new medical device regulation (MDR) being applied since 26 May 2021: to get the CE marking, a device involved in the care of a patient must show evidence of effectiveness. This clinical evidence also helps HTA authorities in different countries determine the acceptable price.

For example, Orla’s PEF remote monitoring has been used and evaluated in the primary health care in the city of Hämeenlinna. The results show a significant improvement in the use of resources: in the past, about 25% of asthma diagnosis and follow-up visits in Hämeenlinna had to be renewed due to poor PEF monitoring. This problem and waste of resources was virtually eliminated when PEF remote monitoring was introduced.1)

Digi-HTA makes recommendations

Digi-HTA is a vital metric for both manufacturers and buyers. It can be used to reach a consensus on an acceptable input-output ratio and reliability, as well as facilitate the introduction of new solutions. Orla is committed to using the Digi-HTA process to assess the effectiveness and pricing of both already launched, as well as upcoming, treatment solutions.

Long-term development work

Orla DTx is a Finnish company developing digital therapies (DTx), who wants to help health care take advantage of digitalization. “Thousands of patients have already used our INR and PEF remote monitoring solutions. We develop new solutions and we work in collaboration with health care, global pharmaceutical-, diagnostic- and MedTech-companies.”, says Pekka Männistö, Head of Market Access.

1) Tapanainen ja Merivuori. Kohti parempaa astman hoitoa – perusterveydenhuolto merkittävässä roolissa. Duodecim 2019;135:1745–52.