Quality Policy and Standards
As a technology leader in mobile health (mHealth) solutions for mental health, Monsenso is ISO 13485 certified. ISO 13485 is the gold standard for medical device companies to ensure the quality, safety and efficacy of products in the medical device field. This certification ensures that the product in question, consistently meets customer requirements and regulatory requirements applicable to medical devices and other related services.
“Monsenso adheres to the highest security standards. Beyond, being ISO 13485, Monsenso holds the ISO 27001 certifications, a TGA certification and class 1 CE mark.” says Thomas Lethenborg, CEO at Monsenso.
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This blog post was written by Anne Zieger, CEO at Zieger Healthcare Communications. It was originally published in the Zieger Healthcare Blog and it is © published with the permission of Zieger Healthcare.
Like many Americans, I have a family member with a major mental illness who sometimes needs inpatient hospital care. Because I have been a healthcare researcher and journalist for 25 years, I’m particularly well prepared to help him navigate the system and get him the attention he deserves.
But there’s one issue which crops up again and again, and despite decades of trying I haven’t been able to find any kind of remedy. And as far as I can tell, this policy — which is universal in my region — actually encourages the delivery of substandard care.
As many people are aware, there’s far too few inpatient mental health beds in many regions of the country. My sense is that the problem may be a bit less acute where I live, in metro DC, as my relative can generally find inpatient care when he needs it. But which bed in which hospital? That’s another story.
Like any other service, inpatient mental health treatment can vary substantially from one institution to another. And as a member of a family support group for mental health problems, I get lots of feedback on which psych units are well-staffed, clean, efficient, thorough, kind to patients and good with discharge planning. (Of course, I also have my relative’s feedback and my own impressions to refer to as well.)
However, area hospitals with psych units absolutely, categorically refuse to tell patients or their families whether a bed is available. Yes, they will typically tell a psychiatrist with admitting privileges whether they can take additional patients, but for reasons which are not clear to me, a shrinking number of psychiatrists choose to obtain such privileges. In fact, in many years of trying, my relative hasn’t found a single one who does do direct admissions.
So here’s what happens. Our family realizes that he needs help, so one of us takes him to a hospital where he feels comfortable and safe. That hospital puts him through several hours of “medical clearance,” and only then do they let us know that there are no open beds there. Then they try to convince us to take whatever bed is available anywhere they can find.
In the most recent case, they pressured us to send him to Hospital X, an underfunded, poorly-rated facility which I’d dearly love to see decertified and closed. Since his episode seemed to be tailing off, we decided to take him home and bring him to another good facility the next day, which we did, successfully. But given the coercive nature of the original facility’s approach, it took all of the strength we could muster to do so.
I am certainly aware that with the limited availability of psych beds, every hospital will turn patients away at times. But if the hospitals let patients and/or family members know whether there was even a chance of admission, patients could make informed choices. They could also choose between their preferred hospitals, rather than being side-tracked into those that did not deserve their patronage.
My guess is that such hospitals, whose psych units are often unprofitable, are colluding to make sure that the more effective, humane and resource-rich psych units don’t get all of the traffic. After all, if patients don’t know which units can serve them, it’s easier for facilities to ricochet them across the region and give some of the inpatient days to whichever player is next in line.
But even if there’s no conspiracy involved, the policy of keeping patients out of the loop is unconscionable nonetheless. If patients end up wherever they’re sent, hospitals have no incentive to offer improved services. And that just about defines “anti-competitive.” I dearly hope someone calls these hospitals to account someday.
To view the original blog post click on this link: http://www.ziegerhealthcare.com/2016/08/21/hospital-policies-make-it-tougher-to-get-high-quality-inpatient-mental-health-treatment344/
According to a recent statement by the new American Heart Association (AHA), major depressive disorder and bipolar disorder should be recognized as moderate risk factors for atherosclerosis and early cardiovascular disease. 
In 2011, the National Heart, Lung and Blood Institute identified four conditions (chronic inflammatory disease, human immunodeficiency virus, Kawasaki disease, and nephritic syndrome) that lead youths to a mild risk of developing cardiovascular disease before they reach 30. 
The statement released a few days ago, reveals that depression and bipolar disorder meet the same criteria as these conditions. Moreover, these two behavioural disorders are more widespread than the previous mentioned conditions combined.
These studies showed evidence of a link between paediatric depression and bipolar disorder with premature cardiovascular mortality. Cardiovascular risk factors for these teens include obesity, insulin resistance and diabetes, dyslipidemia, and hypertension. According to the statement, depression and bipolar disorder are the first- and fourth-most disabling conditions, among adolescents worldwide.
After the report had been unveiled, researchers from schools around the U.S. and Canada looked at existing studies on mood disorders in people under the age of 30. Researchers looked specifically into youths suffering from depression or bipolar disorder with cardiovascular markers such as high pressure and cholesterol. They found a significant connection between having depression or bipolar disorder and increased odds of high blood pressure, high cholesterol, obesity (especially belly fat), type 2 diabetes, and hardening of the arteries. 
This discovery denotes that healthcare providers should track physical activity levels and food intake as well as metabolic monitoring is crucial for these young patients as a preventive measure.
However, to monitor cardiovascular markers, physical activity and food intake, of thousands of young patients who also suffer from mental illness is not an easy task. Although, there are hundreds of smartphone applications tracking physical activity and counting calories, these apps are personal, and clinicians do not have access to an individual’s data. Nevertheless, with the Monsenso mobile health (mHealth) solution, this cumbersome task becomes easy and achievable.
The Monsenso mHealth solution enables clinicians to access a patient’s data on a daily basis. Every day, youths would be reminded to fill in a self-assessment with important information that could include the number of hours they slept, the amount of unhealthy food they have eaten, and if they realized any physical activity throughout their day. Additionally, the smartphone can also collect physical activity and mobility data, based on the smartphone’s inbuilt accelerometer and GPS locator.
The Monsenso mHealth solution, especially designed to monitor behavioural data of patients suffering from mental illness, can in this way help clinicians monitor any unhealthy habits of patients with risk of developing cardiovascular disease.
Further, with the customisable action plans, each youth could follow “contingency plans” if they experience some symptoms related to their mental illness or if they have engaged in unhealthy activities. For example, a special trigger could set up if a youth has indulged in unhealthy food for several days in a row, or has had a low level of physical activity. The action plan listed for this trigger could then encourage individuals to engage in physical activities and and to try to avoid sugar and fat during the upcoming week.
 Browser,D Medscape. Depression, Bipolar Disorder in Teens are CVD Risk Factors: AHA (2015, August 10) http://www.medscape.com/viewarticle/849312
 American Heart Association. Young people with mood disorders have increased risk of developing early cardiovascular disease (2015, August 11)
 Walton, A Forbes. Teens with depression, bipolar disorder, should be screened for heart disease, experts say. (2015, August 11) http://www.forbes.com/sites/alicegwalton/2015/08/11/depressed-teens-may-be-at-higher-risk-for-heart-disease/
Goldstein BI, Carnethon MR, Matthews KA, et al. Major depressive disorder and bipolar disorder predispose youth to accelerated atherosclerosis and early cardiovascular disease. Circulation 2015.
Monsenso will begin clinical trials to support the treatment of anxiety disorder in collaboration with The Mental Health Services in the Region of Southern Denmark (MHS).
The Anxiety Monitoring Study
The objective of the study is to implement and validate the Monsenso mHealth solution to support the treatment of anxiety disorders.
The Monsenso mHealth platform uses a double-loop treatment model to connect care providers and individuals. Currently, it is being used to collect patients’ self-rated status and sensor-based behavioural data on a daily basis.
Recent advances in mobile technologies have created more opportunities for assessments and treatments to be available to people in situations where they are most needed. Personal health technologies can collect patients’ self-rated status and sensor-based behavioural data (e.g., physical activity, phone usage, social activity) on a daily basis.
The information gathered this way provides feedback on treatment progress to both care providers and individuals. Moreover, it also supplies ecological momentary interventions (EMI), for instance, by prompting individuals to do assignments depending on the context and patients’ current status.
Regarding anxiety disorders, mobile health solutions can be useful in assisting patients to use skills learned during treatment in real life situations, as well as to monitor and give feedback on progress or lack of progress during therapy. This feedback leads to better outcomes for patients not responding well to treatment.
Pilot study: The feasibility of the solution will be evaluated using a qualitative and quantitative study without a control group involving 30 patients for three months examining usability and usefulness of the solution for both patients and clinicians.
Participants: Anxiety Patients in Routine and Special Care Settings in Southern Denmark.
Expected results: The study will result in the development of a solution based on user needs. The platform will be a feasible, usable and useful intervention.
Implementation: If the results of the feasibility study are promising, the study results will be used to improve the mHealth solution and develop version 2. Afterwards, a randomised controlled trial (RCT) will be conducted to examine outcome related effects of the solution, such as rate of recovery. If the feasibility and outcome of the RCT studies are positive, it is expected that there will be interest in implementing the mHealth solution in routine and specialized care settings around the world.
To read the press release, click here.