Imagine you live in the country, your child is ill and the nearest doctor is 20 kilometres away. You have an appointment for a check-up and a whining child in the child seat. Wouldn't it be ideal if your doctor could simply monitor the healing process of your child online using an app and intervene if necessary? This may not be as far away in the future as it might sound.
The new German law of the Federal Ministry of Health, "Digital Care Act (DVO)", will in future provide reimbursement of health apps by the health insurance companies. However, it is not yet clear when this will come into force.
On behalf of the German Federal Ministry of Health, the Bertelsmann Foundation is currently developing a quality criteria catalogue for the evaluation of health apps, which will serve as a quality guideline for the prescription, reimbursement and use of health apps.
This catalogue of criteria is still in progress and is not expected to be published until the end of 2019. Only then will health insurance companies have concrete criteria for the reimbursement of health apps.
Through cooperation agreements between companies and health insurance funds, individual health apps, such as the ones for tinnitus, mental health or Parkinson's disease, are already being reimbursed.
Health apps serving primarily for the prevention of a disease are already being reimbursed. These are tested by the Central Testing Laboratory for Prevention. Currently there are already 176 prevention apps, which are covered up to 100% by the health insurance companies. This number is continually increasing.
Today is the first World Patient Safety Day worldwide. In order to protect the safety and the best interests of patients in clinical studies, we implement the highest ethical standards and the appropriate regulations in all our studies. This is how we gain the trust of our customers and patients, even when conducting clinical studies with children. Recently, MEDIACC submitted a comprehensive ethical application for a study with an innovative medical device with professional athletes. By carefully choosing the endpoints and intensively training the study centres we can make sure that the study conduct will be performed according to the highest safety standards.
According to § 23b of the Medical Devices Act (MPG), there is an exception to the requirements of a clinical trial of a medical device (according to §§ 20 to 23a), as long as the corresponding medical device may carry the CE marking and a clinical study is conducted according to the intended purpose of the medical device without additional invasive or other stressful examinations. These studies can then be carried out, for example, in accordance with the medical professional code of conduct for physicians.
In such clinical studies, the product is tested according to the purpose defined by the manufacturer. In the literature, "invasive" means that an examination is carried out specifically for the purpose of the study, e.g. taking blood. Whether a clinical examination is burdensome must be weighed and assessed in each individual case on the basis of various factors and measures that have already been evaluated as such.
Clinical studies according to §23b MPG are not explicitly regulated in MDR 2017/745, which also applies to clinical studies for medical devices. In Germany, these studies will continue to be regulated under national law in the future. At present, there are no new regulations at the national level. (Information from a Notified Body in Germany, September 2019)
Such studies, which may include post-market clinical follow-up (PMCF, Annex XIV) or post-market surveillance (PMS, Article 83) under the above conditions, shall in principle be designed, planned and conducted in strict compliance with good clinical (ICH-GCP) and scientific practice, in accordance with the professional code of conduct for physicians and other applicable laws, regulations and standards.
However, "incidents" in such a study must be reported by the manufacturer, i.e. the sponsor of the study, to the authority from January 2020 on a "Manufacturer Incident Report for Serious Incidents and Incidents". This also applies to studies that have already begun.
This allows the effect, benefit, side effects and safety to be demonstrated and proven.
Since its foundation in 2013, MEDIACC has been continuously growing. During our successful work on preclinical and clinical studies, including observational studies and the reimbursement of medical apps, we were able to welcome new employees and thus slowly exceeded our old office capacity. We, furthermore, expanded our sphere of activity. As of August 26, 2019, our base is located at
– very close to our old location, right in the middle between the underground stations Berliner Straße and Güntzelstraße.
Immediately on the first day after the move, MEDIACC resumed its work. Our service for you in the new environment will not only remain at the same superior level, but will even improve from now on! Having been committed to excellence for many years, MEDIACC will continue to assist you with all questions and problems related to the ever-growing healthcare market.
We look forward to welcoming you at our new place of action!
MEDIACC is well prepared for the application of the European Medical Device Regulation (MDR 2017/745) on Clinical Studies.
Time flies for manufacturer of medical devices and developers of medical apps. The EU MDR 2017/745 will be applicable on May 26th 2020. Transitional arrangements are put into place by the Notified Bodies. However, for medical devices requiring Clinical Studies, the MDR is binding in case last patient / last visit is not finished by this date.
MEDIACC’s employees now received the certificate on Clinical Evaluation and Clinical Studies according to EU MDR 2017/745 by Germany’s first and only designated Notified Body for EU MDR. As certified partner on the side of our clients, we make sure to keep gold standards such as the Declaration of Helsinki and ISO 14155:2011 as well as implement necessary changes as mandated by the new regulation to protect patients’ rights and safety and increase medical device effectiveness in the EU market.
An interesting feature of the Medical Device Regulation is that words such as “Safety”, “Clinical Data”, “Clinical Evaluation” and “Post Marketing Surveillance” are at least seven time more often used than in the Medical Device Directive (MDD 93/42/EEC).
Data of 31 patients have been used in an international paediatric clinical evaluation for an innovative assistive medical device to show improved clinical outcome (94% of users) when used in addition to standard therapy. Thanks to the proficient cooperation with our university partners and clinical experts, quality of data was first-rate due to meticulous attention to details and expert knowledge. In short time, results could be published in a highly ranked free full-text peer-review journal to change therapeutic perspective for people with physical disabilities.
Our special thanks go to our patients and their families who gave their consent for their data being used – thank you!
The Berlin University Alliance, including the Charité, has won the Excellence Initiative for top university research. The German government will provide an additional 200 million Euros over the next few years to support excellent university facilities for outstanding research projects.
We congratulate all stakeholders and our cooperation partners on this great success. The funding will enable to further develop the cooperating university locations and Berlin as a top international science location.