How to Market a Health App

Health apps: medical applications on prescription

The market for health apps is growing all the time. Smartphone users will find a wide range of health apps to download in their app stores. Apps are offered for patients and consumers in the areas of fitness and health and medical treatment who

  • inform, offer preventive measures and support with training or nutrition,
  • Measure, save and evaluate medical values.

Health app providers are often IT companies, pharmaceutical companies or health insurance companies. Health insurance companies are primarily involved in the area of ​​prevention and service offers.

What are health apps?

There are different types of health apps:

  1. So-called "Lifestyle" apps, e.g. fitness trackers, nutrition and exercise apps: They can help to support health-conscious behavior.
  2. More service-oriented apps remind you to take medication, monitor the vaccination status, remind you of early diagnosis examinations, offer the possibility to make doctor's appointments or serve as a diary to monitor symptoms or the progress of an illness.
    More and more health insurance companies are offering their members their own health insurance apps as a service, which facilitate online communication with the health insurance company, help with the search for a doctor or with the help of which health data can be managed.
  3. There are also medical appswhich are used for the diagnosis and / or therapy of a disease, such as the evaluation of blood sugar levels.
    Medical apps must be approved as a medical device and bear the CE mark. However, the CE mark says nothing about the health benefits. Due to legal regulations, apps are now considered as medical devices and must then also meet the higher requirements.

Health apps on prescription

With the entry into force of the "Digital Supply Act" (DVG), certain health or medical apps can become a health insurance benefit for those with statutory health insurance. One speaks of "digital health applications", or "DiGA" for short, which are listed in a separate directory.

The first applications recorded in the DiGA directory offer help with tinnitus and certain anxiety disorders, but apps against back pain, to help with depression, apps that help with taking medication, digital diaries for diabetics or support apps for migraines and pregnancy are also possible . In general, apps that offer support in recognizing, preventing, alleviating or treating illnesses, injuries or disabilities come into question.

The health insurance company can cover the costs, if

  1. these apps have been checked by the Federal Institute for Drugs and Medical Devices (BfArM) for data security, data protection and functionality. The list has been available at https://diga.bfarm.de/de since the beginning of October and is constantly being expanded.
  2. Your doctor prescribes an approved health or medical app for you.
  3. a well-founded diagnosis is required as a prerequisite.
     

But it is also possible without a doctor's prescription. A health app can also be used with the approval of the health insurance company. For this, however, one must prove a corresponding indication, i.e. a reason for a therapeutic or diagnostic measure in the case of certain symptoms, for example through treatment documents.

If the BfArM has checked an app and added it to the "Directory for digital health applications", it will enter a test phase. The health insurers then bear the cost of the app for one year. During this time, the app providers have to prove that their software contributes to better medical care for users. If they provide evidence of positive supply effects, the app will be permanently included in the directory. If they only provide indications of psowitive care effects, they are provisionally included in the directory for twelve months.

The rules don't just apply to new apps. Applications that are already available can also be included in the directory if the test is positive. However, the manufacturer must submit the application.

Providers have been able to submit an application for an examination to the BfArM since mid-May 2020. Approved applications can then be reimbursed by the statutory health insurance companies. Only apps with a CE mark are eligible for the list. The details of the test are regulated in an ordinance issued by the Federal Ministry of Health on April 8, 2020.

If your doctor prescribes an app for you and questions arise about it or if you have doubts about its usefulness, it is best to talk to the doctor.

How do you get a tested app from the DiGA directory?

Doctors and psychotherapists can prescribe apps from the DiGA directory. This prescription (still in paper form in the initial phase) must be submitted to their health insurer by those with statutory health insurance. You will then receive a code with which you can download and activate the app free of charge. However, doctors are not obliged to prescribe apps.

Hasn't there been uniform quality criteria for health apps for a long time?

With every app, the question arises as to whether the underlying information is correct and from which sources it comes.

So far, there are no uniform quality criteria and no mandatory information on the intended purpose, the areas of application and user groups and limits to the use of health apps.

Most apps in this fast-moving market have also not been scientifically tested for their usefulness. There may be helpful apps, but also those whose use has not been proven and which, in the worst case, can even cause damage, e.g. through incorrect measurements and diagnoses.

It is all the more important that you discuss apps that offer more than just small gimmicks (e.g. pedometers) with your doctor.

In addition to the BfArM's DiGA directory, a directory of the Bertelsmann Foundation, which evaluates digital health applications, offers a first orientation. There health apps for areas such as cardiovascular system, muscles / bones / joints, diabetes, psyche and migraines are listed and evaluated for their medical benefit, technical quality, consumer protection and user-friendliness, among other things. However, as with the BfArM, the assessment is based on the manufacturers' self-reports.

How secure is data protection?

Basically, many apps are about data protection to be assessed very critically. In many health apps, sensitive data is collected, stored and processed.

As a user, with many apps you do not know who you are entrusting sensitive data with. Experts see this as a major problem. In any case, it is advisable to read the general terms and conditions of an app and to check which data the app retrieves and whether it may forward this to third parties.

Even the download of an app leaves traces. That is why it was also discussed whether the App Store or Google Play as a source of supply is acceptable at all for apps that are prescribed by doctors and paid for by health insurers. For the tested medical apps in the DiGA directory, however, data protection is a major part of the statutory ordinance of the Federal Ministry of Health. The prescription apps must, among other things, be free of advertising, personal data must not be used for advertising purposes and medical content and health information must correspond to the generally recognized professional standard.

How should you choose an app?

With the following questions we want to give you some guidance.

Ask yourself:

  • What function should the app fulfill? Does the actual function match the promised?
    Danger: Free programs often have a very limited range of functions. If you want more, you have to pay.
  • Who is the manufacturer of the app: a scientific institute, medical professionals, pharmaceutical companies, health insurance companies? Does anyone have an interest in selling their products to you?
  • How is the app financed? Is advertising shown, are sponsors named?
    Danger: Free apps in particular are financed through data trading and advertising.
  • Is the advice and information understandable?
  • Are the data / values ​​output plausible? Do the measured values ​​(e.g. blood sugar values) differ significantly from the values ​​measured by the doctor?
  • If the values ​​are critical, is it advised to seek advice from a doctor?
  • What should the app be able to do, what does it have to ask of the user? Does the app, for example, require access to the address book even though it only has a pure documentation function?
    Ask yourselfwhether the required access authorizations are actually necessary for the app to function.
  • Are there any instructions on how data will be passed on to third parties and if so, to whom and for what purpose will the data be passed on?
  • Where is the data stored: on your smartphone / tablet or externally at the provider?
    Danger: If you save it externally, you may lose control of the data.

This content was created by the consumer centers in North Rhine-Westphalia and Hesse for the network of consumer centers in Germany.