Presentation by Moritz Dietsche (Haako) at the DayOne Expert Event Legal challenges and opportunities for digital health innovation. it is essential to address the legal aspects early on and make them part of the solution. This was shown by this start-up showcase:

1. Breathe
Empowering parents of children with asthma.

3. Topics
• Data Protection (GDPR)
• Software as a Medical
Device
• Intellectual Property?

4. General Data Protection Regulation
How can we handle online patient data that is created, accessed
and modified by both parents and healthcare professionals?

5. How can we handle online patient data that is created, accessed
and modified by both parents and healthcare professionals?
Understand the requirements!
General Data Protection Regulation

6. General Data Protection Regulation
How can we handle online patient data that is created, accessed
and modified by both parents and healthcare professionals?
Understand the requirements!
Store data locally, only collect anonymized data.
Only share a copy with the HCP (end-to-end encrypted).

7. Medical Device Regulation
Do we build a medical device?
Should we do it?

8. Medical Device Regulation
Do we build a medical device?
Should we do it?
Seek expert advice and consider the market.

9. Medical Device Regulation
Do we build a medical device?
Should we do it?
Seek expert advice and consider the market.
We could have avoided it if we wanted.
Requirement for reimbursement under Digital Care Act (Germany).

10. Protecting our IP
Patents?
Design & trademarks?

11. Protecting our IP
Patents?
Design & trademarks?
Our asset is our understanding of the end users.

12. Moritz Dietsche
CEO
+41 61 511 52 71
moritz.dietsche@haako.io
Marko Kocic
COO
+41 61 511 52 72
marko.kocic@haako.io
haako gmbh
Gewerbestrasse 24
CH-4123 Allschwil
www.haako.io