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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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.
Attention deficit hyperactivity disorder (ADHD) is a common neurobiological condition affecting 5-8% of school-age children.
Borderline disorder is a behavioural illness marked by unstable moods, behaviour and relationships.
The disorder usually begins during late adolescence, not before the age of 18 years. However, early symptoms may occur during childhood.