Monsenso digital health solution is HIPAA compliant

Monsenso digital health solution is HIPAA compliant

Monsenso A/S, a technology leader in digital health solutions for mental health is HIPAA compliant. The Monsenso digital health solution that connects individuals and clinicians to provide optimal care adheres to the highest standards for data security and privacy. In addition to being HIPAA compliant, Monsenso holds ISO 13485 and ISO 27001 certifications, Cyber Essentials certification, a TGA certification and class 1 CE mark.

The Health Insurance Portability and Accountability Act of 1996 (HIPAA) was enacted by the U.S. Department of Health and Human Services (HHS) and is a federal law that mandates the creation of national standards to protect patients’ sensitive health information from disclosure without their consent or knowledge.

To read more about our data protection, download our Data management & Security fact sheet.

About Monsenso

Monsenso is an innovative technology company offering a digital health solution. Our mission is to help provide better mental health to more people at lower costs. Our solution helps optimise the treatment of mental disorders and gives a detailed overview of an individual’s mental health through the collection of outcome, adherence and behavioural data. It connects individuals, carers and health care providers to enable personalised treatment, remote care and early intervention. Based on continuous research and development, our team is committed to developing solutions that fit seamlessly into the lives of individuals, increase their quality of life and improve the efficacy of mental health treatment. To learn more visit www.monsenso.com.

For additional information contact:

Bettina van Wylich-Muxoll
Chief Marketing Officer
Monsenso
+45 22 70 47 24
marketing@monsenso.com

Patient Voice in RWE: generating evidence that will impact payer and HTA decision-making

Patient Voice in RWE: generating evidence that will impact payer and HTA decision-making

With the rise of patient-centered medicine and accelerated approvals, health technology assessment (HTA) bodies and payers are looking to real-world evidence (RWE) to strengthen evidence packages and reduce uncertainties at the time of launch.

Increasingly, stakeholders are recognizing the importance of RWE that incorporates patients’ real-world experiences in understanding what treatments work, and for whom, in clinical practice.

Real-world evidence is generated through applying data science to real-world data (RWD), or data “relating to patient health status or the delivery of healthcare routinely collected from EHRs, claims, registries, patient-reported outcomes, devices/applications, etc.” Decision-makers are exploring how this evidence can supplement clinical trials and provide additional context on the effectiveness of therapies.

There is some overlap between patient experience data, which provides information about a patient’s experience with a disease or condition, and real-world data (RWD), however, they are not one and the same. For example, patient-reported outcomes (PROs) collected in an electronic health record (EHR) would be considered both RWD and patient experience data, however, lab test results in the medical record would be considered only RWD. As personalized medicine continues to gain traction, decision-makers like ICER, FDA, NPC, EMA, EUNetHTA, and EHDEN are calling for patients’ voices to be included in the drug development and assessment process. Such information – direct input from patients on how they feel and function is often lacking from RWD sources, and FDA and EMA identified such missing data as problematic for interpretation.

We spoke with Ashley Jaksa MPH, Scientific Partnerships Lead, Aetion and Chung Yen Looi, DPhil Partnerships Director, Monsenso, about the evolving landscape of patient experience data and how biopharma organizations can incorporate the patient voice into their RWD and RWE programs.

Q: Ashley, can you tell our readers a little more about what Aetion does? 

AJ: Aetion is a healthcare technology company that uses routinely collected health care data to generate RWE on the safety and effectiveness of medical treatments and technologies. We were founded by Harvard epidemiologists to develop a way to conduct scalable and transparent RWD analyses at the highest level of scientific rigour. Our RWE analytics platform helps biopharma organizations, regulators, HTAs, payers, and other researchers generate RWE to inform decisions on the safety, effectiveness, and value of medical interventions across the product lifecycle. Our platform is data fluent, meaning it can analyze almost any type of RWD, and we often work with our customers and partners to identify the most fit-for-purpose data set for their research question.

Q: Why is the patient experience important for biopharma to understand, and where in the drug development lifecycle is it most important to integrate patients’ voices? 

CL: I think we can all agree that pharma and its stakeholders want to develop safe and effective drugs and bring them to market, to improve patients’ lives. As such, asking patients directly about how a drug impacts their lives is critical. Without the patient voice, we will never know how patients experience therapies in the real world, and how medical interventions could make a meaningful difference to their lives. Capturing and incorporating the patient voice across the product lifecycle can help biopharma companies to better understand the real-world impact of their drug, treatment responders, and meaningful endpoints based on a wider, representative population, in a quick and cost-effective way. 

AJ: Similar to RWE, patient experience data is important in almost all stages of the product lifecycle—not just as a post-marketing exercise. For example, understanding the treatment pathways and patient experiences on first-line therapies can help shape what comparators and outcomes should be captured in future randomized controlled trials to differentiate the drug in the market.

Q: How can incorporating the patient voice improve market access?

CL: Patient voice is a powerful way to demonstrate the impact of a drug on patients’ quality of life to payers and HTA bodies, particularly for cost-effectiveness evaluations. Some biopharma organizations have used PRO measures on daily functioning and health-related quality of life as their primary and secondary endpoints in clinical and real-world studies, while others have directly linked PROs to their drug reimbursement contracts. Patient voice contributions can help biopharma companies differentiate their product from similar drugs for coverage, especially for payers who are tying reimbursement to the value to patients based on outcomes and have longer-term responsibilities for their populations.  Some of the common myths are that “payers don’t care about PRO evidence, PROs only matter if they make it to the label, and that PROs should only be collected in Phase IV.” The facts are that not all payers are alike. Some pay a lot of attention to PRO evidence. Payers will consider all data from pivotal trials, whether or not it is on the package insert, and coverage decisions will be made on pivotal trials, so waiting until Phase IV to collect PROs would be too late.

Q: What are the common barriers in generating high-quality, patient-centric RWE?

AJ: I think the common barriers to generating RWE and patient-centric RWE are very similar; researchers must ensure that the data exists, that the data is capturing the relevant underlying medical concept, and that it is generated in a way that limits bias and confounding. Traditional RWD sources, like claims and EHRs, often have limited patient-centric data. This is a challenge for researchers attempting to incorporate this information into their studies. However, groups like Friends of Cancer Research and data providers like Monsenso are working to ensure this information is being collected. Once it is collected, it is essential to validate that these data and algorithms are actually measuring what we are intending to measure. Finally, researchers must be cognizant of bias and confounding and control for this as much as possible through study design and analytic methods. 

CL: Adding to Ashley’s points, I think data privacy and security, patients’ burden of contributing to research, and standardized methodology to analysis and interpretation are common barriers. It may seem like a no-brainer to ensure that patient data is managed in a secure way, but a recent study showed that almost a third of health apps out there collect patient data without privacy policy, and about one in five data transmissions occurred on insecure communication protocols. Furthermore, as patients are already suffering from their disease or conditions, contributing to research could add to their burden, which is why data capture platforms should be designed in a way that is easy-to-use and that provides valuable insights to patients. Finally, there is a lack of standardization in analysis and interpretation—which is why companies like Aetion are important to ensure that critical questions are answered, data sets are relevant, and standards are followed to derive and present meaningful insights that will inform decision-making.

Q: How can biopharma generate high-quality, patient-centric RWE for decision-makers? 

AJ: In addition to addressing the common barriers mentioned above, we think it is important to follow a principled approach to study design and execution. The main reasons why decision-makers like regulators and HTAs/payers dismiss RWE are due to deficient data selection and insufficient methodology. Following principled epidemiologic methods of selecting fit-for-purpose data, avoiding common methodological mistakes, and ensuring the protocol and results are clearly communicated are essential to ensuring the decision-makers trust the evidence. This planning and execution of RWE studies is not easy; it takes forethought. Biopharma manufacturers should be considering RWE at every stage of the product lifecycle, and proactively planning for how RWE studies will be incorporated into each product’s launch. 

Q. What is the cost-benefit for biopharma of generating patient-centric RWE? 

CL: Relative to the costs of bringing a new drug to market – which could go up to billions of dollars and take over a decade, with limited success ratesthe costs associated with collecting patient-centric RWE is insignificant. In return, patient-centric evidence could provide significant savings and valuable insights as early as possible to ensure that new drugs are truly driven by patients’ unmet needs, that they impact outcomes that matter to patients, and, ultimately, that they have the greatest chance of reaching the market and making a meaningful difference to patients. 

AJ: RWE can provide value for biopharma organizations across the product lifecycle—from eliminating costs typically incurred during clinical trials to accelerating time to market. Using a validated RWE platform can take this a step further, allowing companies to run more efficient, credible studies and reach insights faster than they could with traditional line programming. By ensuring patient-centric outcomes are collected in clinical data sources, then incorporating patient-centric RWE across drug development and commercialization programs, biopharma organizations can unlock insights that deliver value not only for their company but for patients as well. 

Q: Lastly, for our readers who are not familiar with Monsenso, Looi can you kindly tell a little more about what Monsenso does? 

CL: of course, Monsenso is a digital health company that enables patient-centric care and research. We’re a spinout from the IT University of Copenhagen based on the groundbreaking research of Professor Lars Kessing and Dr. Mads Frost on bipolar disorder and depression. We were founded in 2013 and have been listed on Nasdaq First North in Denmark since 2020. Our solution enables pharma companies to collect self-reported and device-generated data directly from patients in a simple, scalable, secure, and cost-effective way. Our cloud-based platform connects patients and investigators via an app and a web portal, respectively, to collect data in real-time across clinical development, post-market studies, and clinical practice to inform decision-making. Our platform can integrate with wearable devices and sensors, and combine with other RWD sources to provide a more holistic view of the impact of a drug on patients’ lives.

Empowering patients with digital technology

Empowering patients with digital technology

On the previous blog post, “Transforming health and social care with digital technology” connected health or technology-enabled care (TEC) was defined as the collective term used for telecare, telehealth, telemedicine, mHealth, digital health, and eHealth services. This type of technology can empower patients and carers by giving them more control over their health and social care needs. It can also help individuals to obtain more information regarding their health.

In broad terms, TEC can:

  • Improve self-management through remote monitoring, education, and treatment adherence
  • Tackle areas of unmet needs that traditional treatment struggles to address, such as mental health
  • Supports the development of online patient portals and patient communities
  • Transforms the relationship between patients, carers and healthcare providers to focus on co-creation

Enables self-management

Nowadays, patients and their carers use technology to research information online, identify treatment options, rate providers, and share their experiences. Healthcare needs to acknowledge that emerging technologies offer a tremendous opportunity to transform the way people engage with their health.

Besides connecting patients and providers, digital technology leads to better outcomes and a more personalised service by educating patients in regards to their health-related issues, enabling remote monitoring, and supporting treatment adherence.

Informs and educates patients and carers

It is estimated that 75% of the UK population goes online for health information. Websites, apps, videos, texts and free online courses are being used to educate and provide information to patients and their family caregivers [1].

Figure 1 displays the most common category of mobile apps: fitness, medical reference and wellness apps, which provide information with other very limited functionalities.

Figure 1. Digital health app category, percentage share in 2014.


Figure 1

The use of digital technology to educate patients and carers is a crucial driver of patient engagement. Surveys suggest that patients are more likely to make better choices and be engaged in their health if they can access information quickly.

Digital technology connects patients and providers, leading to better health outcomes and a more convenient and personalised service, through informing/educating, two-way remote monitoring, and supporting treatment adherence [2].

TEC can help carers understand and support those they care for by:

  • Providing psychological reassurance
  • Enabling carers to co-ordinate their work-life-care balance through supporting flexible hours and remote working patterns (approximately 2.3 million people have had to give up work to become carers and three million have reduced their hours)
  • Delivering peer-to-peer support

Facilitates remote patient monitoring (RPM)

Remote monitoring uses technology to monitor changes in patients’ health status outside conventional clinical settings.

Historically, it allows a patient to use a device to perform a routine test and send the test data to a healthcare provider. Initially, it depended on a healthcare provider recommending its use to patients. However, digital technology has increased the potential for remote monitoring and, with the advent of apps and wearables, patients are increasingly bringing the innovation to doctors [3].

New advances in the development of biosensing wearables are spreading their capability beyond simply tracking activity. New devices can monitor a broad range of physiology (from posture to brain activity) and convert this information into outputs, through advanced connectivity and computing power.

Biosensing wearables can support people with chronic conditions, automating monitoring and detecting real time changes in an individual’s health status. Data from biosensing wearables can be uploaded to an Electronic Patient Record (EPR) and this information can be used to display an overview of a patient’s medical history in real-time, supporting early diagnoses and early intervention.

If a negative change occurs, patients, family caregivers and healthcare providers can be alerted quickly, preventing emergency admissions.

Increases treatment adherence

In bad cases, failure to follow treatment can cause a patient’s condition to deteriorate, leading to an increased likelihood of hospital admission, permanent disability, or death. Electronic reminders and alerts, via text SMS or apps, can remind patients to follow their treatment regimens, thus improving health outcomes.

The World Health Organisation has calculated that adherence to long-term therapies in developed countries is around 50%, and is even lower in developing countries [4].

In the UK, between one-third and half of all medicines prescribed for long-term conditions are not taken as recommended. It is estimated that the cost of unused or unwanted medicine is around 100 million GBP per annum [5].

Improved adherence allows healthcare providers and pharmaceutical companies to obtain a better understanding of the impact of drugs, including any complications or drug interactions, providing useful data for research. An increasing number of pharmaceutical companies are investing in digital TEC projects to increase patient adherence to the drugs they produce. Likewise, patients and carers are increasingly using digital health software to register and monitor medication intake [6].

References:

[1] Valuing Carers 2011: calculating the value of carers’ support, Carers UK and academics at the University of Leeds, May 2011.
http://circle.leeds.ac.uk/files/2012/08/110512-circle-carers-uk-valuing-carers.pdf

[2] Putting patients first. The NHS England business plan for 2013/14 and 2015/16. https://www.england.nhs.uk/wp-content/uploads/2013/04/ppf-1314-1516.pdf

[3] Primary care working differently: Telehealth and telecare –a game changer for health and social care, Deloitte UK Centre for Health Solutions, December 2012. http://www2.deloitte.com/content/dam/Deloitte/uk/Documents/life-sciences-health-care/deloitte-uk-telehealth-telecare.pdf

[4] Medication Adherence: WHO Cares? Mayo Clinic 2011. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3068890/

[5] Aston Medication Adherence Study, Aston University. See also: http://www.aston.ac.uk/lhs/research/health/pharmacy/adherence/

[6] Mobile apps, fighting for patient adherence, Mobile health global, December 2014. See also http://www.mobilehealthglobal.com/in-the-news/news/109/mobile-apps-fighting-for-patient-adherence

[7] Psychological Therapies, Annual Report on the use of IAPT services: England – 2013/14 Experimental Statistics, Health and Social Care Information Centre, September 2014. http://www.hscic.gov.uk/catalogue/PUB14899/psyc-ther-ann-rep-2013-14.pdf