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Value Centre Voucher helps Inzentiz to secure the privacy and security of its innovative CE and FDA approved mHealth platform.

Inzentiz® Medical Software  is developing a software platform that meets  all CE and FDA demands in the highest risk-class (class IIB). The platform can even be used in high-risk applications like sensor-medicine pump closed loops or treatments with radioactive sources.


Hans Meijs, co-founder of Inzentiz: “We saw that a lot of mHealth and eHealth companies were struggling with CE cer­ti­fication: The certification was a bottle­neck for the entrepreneurs since they were too busy to handle all the paper­work needed to meet the Medical Device Directive. But doctors will not, for liability reasons, use uncertified products and the reimbursement for eHealth Apps is there­fore far away. This is a worldwide pro­blem, both in the USA and in Europe.”

To be used widely and to be scalable, the plat­form covers the general functio­na­lity which covers about 80% of the code need­ed by all applications. Domain specific functionality (20%) must then be developed by the manu­factu­rers on top of the platform. The platform can be compared with an Operating System (OS): All nowadays applications are built on top of the OS and don’t need to code the OS anymore.

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Steps to take

Inzentiz started the preparations for the platform 2 years ago: there are a lot of aspects to be con­si­dered. The Inzentiz team started the implementation in April: A recent 200K€ EFRO grant of OP OOST gave the kick-start. But another 700K€ is needed to create the platform.

Meijs: “The next big step is to find investors. When we find 700K€, we can realize the platform and enter the market actively… a senior marketer is on board. The second challenge we face is to find a way to the US market: US mHealth companies are 3 years ahead of EU companies and they also avoided certification so far. More than 1,000 USA mHealth manufacturers are waiting for our platform that  will make certification 3x faster and 3x less expensive.”

CE and FDA certification focus on patient safety but security and privacy are also very impor­tant: The medical and patient-data will be stored in the Inzentiz® cloud and patients must be 100% sure that their data are secure in our cloud. ISAE3000 is worldwide recognized as (one of) the toughest industry standards in defining controls mitigating security- and privacy risks. Deloitte certifies our security and privacy framework using the ISAE3000 standard.

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LS@W Value Centre

The Value Centre Voucher supported the decision for Inzentiz to start the ISAE3000 certification process relatively early. The first step was to recognize the security and privacy risks and define adequate controls. With this voucher Inzentiz could ask Deloitte to assess our risk-framework and risk-mitigations. This work is almost finished and once this is done, Inzentiz can  inform the market that our ISAE3000 framework is approved by Deloitte.

Meijs: “In this way we tell the market that we take patient safety  (CE and FDA, class IIB) very seriously but we are also very serious about patient security and privacy (ISAE3000).”


More information

 

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