Monsenso is ISO 13485 certified

Monsenso is ISO 13485 certified

by | Aug 21, 2020 | News

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.

You can download this article as PDF in English.

For additional information contact:
Bettina van Wylich
Chief Marketing Officer
Monsenso
+45 22704724
wylich-muxoll@monsenso.com

Monsenso is ISO 13485 certified

Monsenso is ISO 13485 certified

by | Aug 21, 2020 | News, Press releases

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 certified, Monsenso holds the ISO 27001 certification and class 1 CE mark.” says Thomas Lethenborg, CEO at Monsenso.

For additional information contact:
Jennifer Highland
Marketing and Communications Manager
Monsenso
+45 81 71 7713
highland@monsenso.com

Transforming healthcare with technology-enabled care

Transforming healthcare with technology-enabled care

by | Jun 17, 2020 | Blog

Connected health or technology-enabled care (TEC) is the collective term used for telecare, telehealth, telemedicine, mHealth, digital health, and eHealth services. TEC is now seen as a fundamental part of the solution to solve many healthcare challenges.

TEC helps people self-manage their health and wellbeing, alert healthcare professionals in case of any changes in an individual’s condition and support medication adherence.

It also helps clinicians and care providers deliver more efficient and cost-effective care.

Digital technology is advancing exponentially, and its cost is becoming more affordable. The need for more cost-effective healthcare is rising. Now more than ever, healthcare authorities need to adopt new technologies to help meet this demand.

Key trends

An aging population

The population is increasing, and people are living longer. These two factors, in addition to a rise in chronic conditions, present new healthcare challenges.

In the United States, population projection reports that older adults currently make up about 15% of the population, and by the year 2060 is estimated to amount to 23.5%.

There are similar numbers reported for Europe, where the group of 65-year old or older make up 19% of the population and is predicted to amount to 29% of the total population by the year 2080.

Use of mobile devices is increasing amongst all age groups

A 2019 report conducted by Provision Living, a senior living community in the U.S.,  revealed that on average, Baby Boomers (born between 1946 and 1964) and millennials (born between 1981 and 1995) spend on average, five hours a day on their smartphones.

Smartphone adoption among Americans:

  • Aged 50 to 59 is 86%
  • Aged 60 to 69 is 81%
  • Aged 70+ is 62%

Other market drivers

The demand for apps and wearable devices is also being driven by an increased focus on personalised care. Large pharmaceutical companies are now using apps and wearables to gather valuable health-related patient data, support their research, and provide an holistic service to patients.

In 2014, the leading pharmaceutical companies had an increase of 63 % in unique apps compared to 2013. In just one year, the total number of downloads of pharmaceutical apps increased by 197% as shown in Figure 1. These apps deliver education and training, can titrate medication and monitor compliance.

Figure 1. The number of apps published by leading pharmaceutical companies, 2013 and 2014.

There has also been an increase in online patient communities, using social media as a platform to exchange experiences with patients and carers.

Increasing patient trust in health apps

There is strong evidence that patients are now more than ever concerned about self-care, and they are interested in boosting their health and wellbeing. In addition to this, health technology companies are working to improve the quality of apps, increase user confidence and trust, and launch informed decision-making in app selection for health professionals, patients and the public.

Agencies like the US Food and Drug Administration (FDA), or NHS Choices and its NHS Health Apps Library have developed criteria that judge apps for safety and technical proficiency. For example, for apps to be included on the NHS Choices search website, which in early 2015 lists around 150 apps, they must be reviewed by a technical team (testing relevance, legal compliance and data protection), then by a clinical team (to test scientific rigour).

PatientView is an independent organisation that has developed a systematic method of appraising health apps. Until April 2015, there were 363 apps recommended for the Apple platform and 236 for Android, with smaller numbers recommended for use on other platforms.

In 2014, PatientView undertook a survey of 1,130 patient group members to identify what people want from health apps as shown in Figure 2.

Figure 2. What do patients and carers want from health apps?

References:

Connected Health: How Digital technology is transforming health and social care. Deloitte Health.

Forget Generational Stereotypes, Baby Boomers Are Just As Addicted To Smart Phones As Millennials. 

Older Adults Keep Pace on Tech Usage.

An Aging Population, Larger Chronic Disease Burden, and Reliance on Digital Self-Management Tools Require Contributions from Nurse Informaticians.

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Hospital policies make it tougher to get high-quality inpatient mental health treatment

Hospital policies make it tougher to get high-quality inpatient mental health treatment

by | Aug 23, 2016 | Blog, mHealth

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.

Anne Zieger

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/

Clinicians to monitor cardiovascular disease markers for teens suffering from mental illness

Clinicians to monitor cardiovascular disease markers for teens suffering from mental illness

by | Jun 21, 2016 | Blog, Mental Illness, mHealth

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.  [1]

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. [2]

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.[1]   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. [3]

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.

References:

[1] Browser,D Medscape. Depression, Bipolar Disorder in Teens are CVD Risk Factors: AHA (2015, August 10)  http://www.medscape.com/viewarticle/849312

[2] American Heart Association. Young people with mood disorders have increased risk of developing early cardiovascular disease (2015, August 11)

http://blog.heart.org/young-people-with-mood-disorders-have-increased-risk-of-developing-early-cardiovascular-disease/

[3] 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.