Digital Medicine Week 2021

Four days, four interconnected conferences, one goal: improving everyday life for patients. Be there when the hih opens the digital gates, giving the stage to patients, medical entrepreneurs, DiGA (app) manufacturers, researchers, experts in evidence generation, medical socieities, certifiers, and MDR experts.

Medical venture validation, DiGA Con, Evidence Con, and MDR Conthe interactive concept behind Digital Medicine Week will offer insights into patientseveryday lives, present patient-centered digital innovations, develop study designs for DiGA, give medical entrepreneurs a stage to present their products to medical societies, health insurers, and VCs, and provide doctors, psychotherapists, and other health care professionals an overview of currently approved DiGA.

Be there as thought leaders and innovators articulate the strategies, challenges, and benefits of a digital, networked health care system.

Formats

MVV – Medical Venture Validation

For medical entrpreneurs, hackers, and patient-innovators

Having an idea is the first step; implementation is typically much more difficult. Medical Venture Validation brings together innovators and implementors to jointly illuminate the daily lives of those living with illnesses, to rethink patient needs, and to realise concrete improvements. This  format is oriented towards invidiauals from all all corners of health care and research as well as patients and their relatives, who have  a concrete idea for a digital product or who want to improve the lives and participation of individuals with illness through a new venture. The MVV can offer multifaceted support – through reality-checks from patient advovates and medical societies, master classes, and a Pitch Day in front of investors as well as health insurance funds.


MVV - Masterclass

Open to all participants

Regulation, medical and health care law, business plans and financing, start-up organisation and development, digital product management. These offerings are targeted at participants with deep medical expertise who are still relative newcomers to venture formation in digital health.

Please note that these sessions will be held in German only. If you feel confident participating in German, you may submit your application by hitting the button below.

Please apply by February, the 12th 2021

Apply

Evidence Con

For researchers

The Evidence Con is a successor to the first Research-a-thon, which took place in February 2019 at the German Center for Cancer Research in Heidelberg. In addition to eminent innovators and researchers who would like to identify studies, designs, and endpoints during the study period, we welcome other interested participants who are interested in testing their ideas and pursuing proof of concept for promising, but still nascent care hypotheses.


Evidence Con – Researchathon

Group Work on dynamic HTAs for digital products & DiGA evidence design.

Please note that these sessions will be held in English only.

Please apply by February, the 10th 2021

Apply

MDR Con

For certification of experimental medical devices, digital health entrepreneurs

The certification of digital medical devices is already a challebnge under the MDD and will become even more significant under the MDR. At the MDR Con, experts in medical device certification will come together with digital health entrepreneurs to discuss how agile, digital product development can be achieved within the requirements of the MDR.


MDR Con – Workshops

Developing best practices for manufactuerer preparation

Developing compliant processes
Creating the relevant supports for technical documentation

Please apply by February, the 12th 2021

Apply

DiGA Con

For manufacturers of prescribable DiGA to-date
Since October 2020, digital health care applications have enriched the German health care and prescription landscape. What approaches are they using? Which paths have they taken? What differentiates them? What study designs have they used for evaluation? As part of DiGA Con, manufacturers of all BfArM–approved DiGA will give structured presentations so that physicians, medical societies, insurers, and patient organizations can get a decisive overview of this new area of health care in a short period of time.

Speaker

Federal Minister of Health Jens Spahn

German Federal Ministry of Health

Before taking office in 2018, the current Federal Minister of Health, Jens Spahn, was Parliamentary State Secretary at the Federal Ministry of Finance. Before that, the political science graduate was the health policy spokesman of the CDU/CSU parliamentary group in the Bundestag from 2009 to 2015. The stated goals of his legislature include the improvement of working conditions for caregivers and the advancement of digitalisation in the health sector.

Dr. Gottfried Ludewig

German Federal Ministry of Health

Dr. Ludewig is a German Politician and since April 2018 Director General Digitalisation and Innovation of the German Federal Ministry of Health. He is responsible for new legislation such as the Digital Care Act (2019) and Patient Data Protection Act (2020). He is in charge of the implementation of the new scheme to assess and reimburse digital health applications as well as the new Research Data Hub. In addition, he managed the development and rollout of the German contact-tracing app (Corona Warn App). Between 2011 and 2018, he has been member of the Berlin Parliament. There he served as speaker for health policy with focus on digitalisation in healthcare. With his current position at the Ministry he aims to promote digitalisation and innovation in healthcare for a better and more efficient health care for patients in Germany.

Jennifer Goldsack

Digital Medicine Society (DiMe)

Jennifer C. Goldsack co-founded and serves as the Executive Director of the Digital Medicine Society (DiMe), a non-profit organization dedicated to advancing digital medicine to optimize human health. Jen’s research focuses on applied approaches to the safe, effective, and equitable use of digital technologies to improve health, healthcare, and health research.

PD Dr. med. Ch. Elsner

University Medicine Mainz

Since 2019 Chief Financial Officer of the University Medical Center of the Johannes Gutenberg University Mainz; previously from 2010-2019 Managing Director of the University Hospital Schleswig-Holstein – Campus Lübeck; previously Head of Healthcare & Pharma at the management consultancy Wieselhuber & Partner as well as various management positions in Switzerland and at RHÖN-KLINIKUM AG.

Prof. Dr. Claudia Schmidtke

German Federal Ministry of Health

Prof. Dr. med. Claudia Schmidtke is a cardiac surgeon. She was elected to the German Bundestag in 2017 as a direct candidate for the Lübeck constituency and is a member of the Health Committee. In January 2019 Prof. Schmidtke took office as Federal Government Commissioner for Patients‘ Affairs.

Bakul Patel

Digital Health Center of Excellence, U.S. Food and Drug Administration

Bakul Patel is the Director of Digital Health Division, at the Center for Devices and Radiological Health (CDRH), at the U.S. Food and Drug Administration (FDA). Mr. Patel is responsible for providing leadership, development, implementing, execution, management and setting strategic direction and regulatory policy and coordinating scientific efforts for digital health, software and emerging technologies.

Prof. Dr. Richard Platt

Harvard Pilgrim Health Care Institute / Harvard Medical School

Richard Platt MD, MSc is Professor and Chair of the Department of Population Medicine, and President of the Harvard Pilgrim Health Care Institute. He has extensive experience in developing systems and capabilities for using routinely collected electronic health information to support public health surveillance, medical product safety assessments, comparative effectiveness and outcomes research, and quality improvement programs.

Prof. Dr. Silvia Schneider

Ruhr-Universität Bochum

Silvia Schneider, PhD, is a researcher in clinical psychology with a strong focus on anxiety disorders in children and their treatment. She is Professor of Clinical Child and Adolescent Psychology and at the Ruhr-Universität Bochum as well as head of the Mental Health Research and Treatment Center in Bochum. She is widely known for her groundbreaking longitudinal studies on children and mental disorders.

PD Dr. Maike Henningsen

Universität Witten/Herdecke, Assistant Professor for Digital Health

PD Dr. Maike Henningsen is a practicing gynecologist and junior professor for “Digital Health”. She holds a master’s degree in innovation management and entrepreneurship and has been advising various institutions on the topic of “Digital Health” for many years. Ms. Henningsen’s goal is to involve physicians more in the dialog on the topic of Digital Health and to promote both medical education and medical research on this topic.

Prof. Dr. Rüdiger Pryss

University of Würzburg

Since 2019, Dr Rüdiger Pryss has been Professor of Medical Informatics at the Institute for Clinical Epidemiology and Biometry at the University of Würzburg. His scientific work focuses on medical informatics, mobile crowdsensing, mHealth, health services research, expert systems and data science in medicine. Prior to his professorship, the computer scientist was a research assistant at the Institute for Databases and Information Systems at the University of Ulm.

Dr. Wiebke Löbker

Federal Institute for Drugs and Medical Devices (BfArM)

Dr. Wiebke Löbker has been the personal consultant to the President of the Federal Institute for Drugs and Medical Devices (BfArM) since 2017 and, since July last year, has also been the Head of the Innovation Office and thus also responsible for the digital health applications that enter the health care system via Fast-Track. Prior to her work at the BfArM, the pharmacist was a scientific advisor with a focus on early benefit assessment according to § 35a SGB V in the Pharmaceutical Departments of the Federal Joint Committee.

Dr. Wolfgang Lauer

Federal Institute for Drugs and Medical Devices (BfArM)

Dr. Wolfgang Lauer has headed the Medical Devices Department of the Federal Institute for Drugs and Medical Devices (BfArM) since 2011 and is, among other things, responsible for the DiGA-register. The mechanical engineer completed his doctorate at RWTH Aachen University in the field of surgical robotics before taking over as head of the research group on Medical Device Usability and Risk Management at the Chair of Medical Engineering.

Dr. Barbara Höfgen

Federal Institute for Drugs and Medical Devices (BfArM)

Dr. Barbara Höfgen joined the Federal Institute for Drugs and Medical Devices (BfArM) in May 2020 as Head of the DiGA Fast Track Unit. Prior to this, the pharmacist spent many years as the Head of Information Systems for Drugs and Medical Devices at DIMDI, where she also held the position of Project leader for PharmNet.Bund and in this role, served as a member of project groups at the EMA on EU Telematics. In addition, she has been a lecturer in the Masters program in Drug Regulatory Affairs at the University of Bonn since 2007.

Sonia Seubert, LL.M.

Mazars Rechtsanwaltsgesellschaft mbH

Sonia Seubert, lawyer and specialist in medical law, is a manager at Mazars. She works in the field of medical device law and has many years of forensic experience in this area. In addition to medical device law, her main areas of expertise include SHI reimbursement law and healthcare compliance. Ms Seubert regularly lectures and publishes on current medical law topics.

Dr. Sven Meister

Universität Witten/Herdecke, Chair of Health Informatics

Sven Meister is a medical informatics scientist, Chair of Health Informatics in Witten and Senior Scientist at Fraunhofer ISST in Dortmund. He is a thought leader for human-machine interaction, health infrastructures and digital competence – always in close contact with the healthcare industry. He is on the board of MedEcon Ruhr, a network of over 150 healthcare institutions.