Digitalisation offers opportunities and possibilities to make workflows and processes more efficient to meet the current and future challenges of the health care system: demographic change, cost explosion and staff shortages.
With the Digital Health Care Act (DVG) and the Digital Health Care and Nursing Modernisation Act (DVPMG) new reimbursement areas were created in Germany in the statutory health insurance (SHI): Digital Health Applications (DiGA) and Digital Nursing Applications (DiPA).
Digital Health Market Access
DiGA and DiPA offer digital health companies in Germany a market access and reimbursement option in the statutory health insurance (GKV) and thus access to a market of 73 million insured persons.
DiGA & DiPA
DiGA are health applications that can be prescribed by doctors or psychotherapists while DiPA need to be requested by insured persons from the long-term care insurance fund.
DiGA and DiPA must fulfill a multitude of specific requirements. Both types of applications must rely on a digital main function and in the case of DiGA a patient centric use and benefit. DiPAs can (but need not) be a certified medical device. Beyond “standard” requirements for certification and General Data Protection Regulation (GDPR), DiGA and DiPA must fulfil specific requirements regarding data protection and security.
For reimbursement outcome studies, positive healthcare effects/nursing benefit in comparison to a control group and in line with the intended use and user group are a prerequisite.
Kalms offers comprehensive DiGA/DiPA assessments based on an internally developed checklist to guide manufacturers through the requirements to market access.