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welcome to the medical device made easy podcast here is money analogy from easy medical device calm and today we will talk about GDP are so I sure you are asking yourself what is GDP are so for that I invited a guest which is Yavin step of each who is the CEO of Chino dot io so it will help us to understand what is GDP are and also the connection between GDP are and MDR so yah man welcome to the medical device made easy podcast thanks honey thanks for inviting me so you want just quick introduction of yourself first maybe for the audience so that they really understand who you are and then we can really jump to the this topic which is your great topic that some people really like about GDP ah so please just introduction you're very optimistic we're talking about regulations and I stopped yeah so I'm as I said I'm the CEO in one of the two co-founders of Qi know your channel is Italian company five years in half of the market we started before our GDP are actually we started 2014 when some issues are regarding privacy and security of health applications were discovered some analysis and we said ok how we can help application developers entrepreneurs they don't so big companies to develop their applications and making sure that they are secure and combined with privacy laws so we created a platform so our platform for developers and this platform offers a set of tools and modules to make health applications gdpr and also HIPAA compliant for US market ok so I think then you have all the information needed for this audience so if you are really developing an application or something so digital application and you are then needed you need if I can say some GDP our knowledge of GDP our tips then Yavin will really help us for that so even as i've said first maybe there are a lot of people that really don't know what is GDP are so can we first mention the acronym what is GDP are and what is also the link to the MDR yeah I quite optimistic actually that people heard about GDP are I'm sure they heard about it but last year they they received a lot of emails from companies saying we updated our process and so on to be Jenny Packham plan GDP are the European general data protection regulation alone applicable in mandatory in all states in Europe it defines general principles on data protection so gently the protection is not data security that much is not technical but it's not also privacy its data protections of what people and what companies need to implement to make sure that a product a website a mobile application and device a device a mobile device is compliant and and protects the users data in a proper way gives the users the proper rights so from last year in has been approved and now it's it's one of the worldwide references for good practices of how what are the subject rights what are the people rights when they use a product they should given the rights to download their data to ported it on another application to ask for the beastial of the day and so but so gdpr is really actually it's really European based so it's really the law of Europe so us is not kind of it's not following GDP are they are not asking I mean they are asking if they have customers in Europe but mainly it's really only for the European Union actually it's true that we received a lot of emails saying to us are you accepting to receive emails from us if you are not you can unsubscribe etcetera just to be sure that we have really asked the permission to get on the list of some of the organizations and for them to prove that yes we opted in so we said yes we want to receive those email and then they are if I can say in the safe side so what is them the link with the MGR so why are we talking about GDP are when we talk also about MDR well yeah so the link is basically that it's not only about our privacy policies this is what we are in in 2018 the GDP are is is about how to design and develop an application to make sure that those rights are implemented properly and MDR makes reference to GDP our and due to data protection of regulations even the the next ones that will be approved like the a privacy regulation it around ten times in the in the room in the NVRA world text as a as a mandatory thing as a mandatory regulation to observe when designing and developing application so MDR quality and and delivering the the promises about medical treatments and medical aspects means also security and privacy and compliance in terms of how you manage the data so it's included okay and now if I am a medical device manufacturer I should I think if I understood well consider gdpr if I'm starting to manipulate data of other people or patients or gathering information from outside the company and storing them inside the company so it's correct yes so as you pointed out previously so the GD P R is 103 every time you start managing personal data of European citizens so also for US companies who are selling their products to European market so they are clearly selling but targeting European cast users European citizens they they need to be GD / compliant if they collect personal data and personal data then there is you know the definition what is personal what is health data and etc so in terms of manufacturers now as they are developing their application or developing there are tools to gather all those data what are some kind of technical requirements that they need to to understand or they need to implement to be on the safe side well unfortunately there are quite many for example there are eight subject rights so some object rides like heard about try to be forgotten so you need to you need to have processes and tools inside your applications on your service that you're offering to track request from citizens to delete the data and to implement that properly so delayed data nest needs to be deleted from backups from from all applications or even from paper if you have some data on the paper so this just one write created really panic in in application development community because it was a what about you know design and implementation so then there is a consent right to consent a constant tracking there is right to object the processing limit the processing limit the profiling and so on so there eight subject right but then there is security there is a restored organization that needs to be implement and there is audit trail and so on so quite many aspects that needs to be consider to make sure that an application is in steady pair compile so um do you have I mean when you are developing an application I think do you need a lawyer to help you understand all this or what is exactly the thing that a manufacturer should consider when he starts to make this application is the regulatory affairs person is it what is what kind of type of people it needs if I can said to be on the safe side well definitely definitely somebody that has knowledge about GDP and legal aspects so it can be a lawyer can be a consultant typically we see these two type of figures helping companies to collect the requirements the challenge is to collect legal requirements and transfer them into technical implementations into design of the application so one definitely one most important or at risk about you declare it has to be considered from the analysis and design of the of the of the software okay while MDR can be considered as a bit further a bit once the prototype is created once you you know you start testing with user and so on GDP only has to be considered from the beginning into implementation and in design so typically how companies do they work with lawyers consultants and they try to implement everything by themself and that's this is costly typically and time-consuming activity and for example that's why we exist at you know your we we are as a company we try to help on that okay so this is something as you as we mentioned that didn't exist before so before what it was what much last year or may last year can't remember way so before that we didn't need that now we need to if I can say update all our applications or all our software's to implement that do you know if there is if it is a high cost if I can set to do all those changes or it's maybe something that is just a form to include or just a small box to include on your software it's a tough question I mean it's a tough it's a painful it's a painful topic why because updating existing applications and to implement those rights and and criterias it's really complicated it's really time-consuming and costly so what we are see in companies with larger applications other applications are increasing some patches some minor changes but those that are building applications right now from scratch the new new kind of services and so on they are considering gdpr from from the beginning so there is this let's say later catch-up on technical aspects so initially we seen all this is updated everybody received a lot of payments but now people companies are implementing practically in new applications in in order it's a bit it's a bit harder but if I understand well because here we talk about MGR mentioning a lot of time gdpr can we say that even if MGR is not here we have to be compliant to gdpr well even even if you're not and they are classified let's say you're if you are not a medical device in cross one or two or three but you collect a personal data or health data even even worst health data you need to be definitely so I think users data must be must be to deter compile okay so yeah I think it's really an interesting topic and I think there is a lot of of also questions from patients actually about what people are doing with my data am i protected can I get them back can I destroy them so that they cannot use them I mean there is a lot of those questions that patients or people are asking because I think they are also afraid that those data are used by some organizations in a wrong way I'm thinking mainly about because it's always those ones that are telling me it's about insurance if they know that I'm not healthy maybe increase my my fee and this and that so I want to know them not to know about my situation so this is a lot of things like that but our other I mean this is a lot of comments I received regarding that but actually what what are you exactly doing at Chino that I you how how can you help the the medical device community to be compliant or what kind of service also you are really offering to them well as I mentioned you know implementing those those subject rights or data security and designing and implementing and delivering properly a GDI compliant application takes a lot of Energy's cost and time and at the end it's also very risky so a risky in case of your cause of failure because we have we have seen very high fines up to 20 million you know four percent turnover but then as I mentioned users are more and more aware about the data and the companies in case of errors can make a lot of can handle can have a lot of damage eaters of trust and reputation so what we do at Chino yo we prevent those risks we eliminate those risks by delivering a technology that makes health applications gdpr compiled and HIPAA compliant also for us market by by technology by this zile by default and by using this technology companies can also save a lot of time and costs so that's it's a technology used by developers and to implement data security implement consent tracking implement audit trails implemented right to be forgotten in many other features okay so I suppose that your main customers are application developer or software developers so do you have also some customers that ask you some support for non medical device application non medical device softwares well we decided to focus on healthcare because we love healthcare we are passionate about it and we know the market so we tried try always to focus on that but the sensitive data are or like healthcare data there are also in other sectors like finance like there are different types of sensitive data like racial they religious biometric union membership etcetera so in all those categories why does it need for further protection encryptions organization then we can help without knowledge ok so where then can people follow up with you work and they know more about you and maybe contact you for giving them your services well the best way is to download material on our website www.irs.gov ER also via our website there is contact forms and ask any question happy to help but we try to give a lot of material for free to developers to the community to educate them because the main issue is that the gdpr was approved but not many technical guidelines on how to implement it or not many cases have been out there so we try to be on top and and pray this material and I see that on your website I saw and I saw that on nicotine that you are posting that you are also an e-book that you are offering so that people really can see the whole flow for considering a software what is inside the software how to classify a software or so so it's kind of some good if I can say things to read for people that maybe have no clue what is the medical device regulation for software because you are just summarizing all the information that are really important for them yeah we try to create different ebooks actually we try to create one ebook about explaining what is different type of data private personal data sensitive a the health data anonymous data pseudo anonymous data you know these categories this is really interesting there is one ebook about it there is one about GDP article requirements and how you can what are those requires how to implement and recently we we observed a huge demand for MDR related questions and answers if you are MBR certified the application can use clouds for example and then we try to answer those questions you know or ebooks or there is once they're beautiful so check them they're available design for salacious freedom yeah so if you want to know some answers to the question that you have just mentioned so please download the e-book get a free access to it I would put anywhere the links on the show notes but you can also go to Chino dot IO and you will see all what what your one is proposing before for you I think it's it's also important that when you are starting a development of a product like that or an application instead of saying maybe I would wait until the end to start thinking about all the regulatory aspect maybe just having maybe a one hour 30 minutes discussion with with your one can help you maybe to go more further and you can really help you to accelerate the development of your probably can be more the right way because yeah I think we had an episode with them with the bills time where we discussed about the fact that yeah there are some companies that are developing their products until the end and then they are starting to do documentation which is really the wrong way to do it and and is something that we try to avoid so yeah start from the beginning and start to ask yourself from the beginning if you there is some regulation that you have to to follow okay the worst if I can add you know the worst thing is to have a technological depth you know documentation it's true that people write documentation at the end and you should be written in the beginning I mean doing right while writing by doing by designing but the technological death the errors that you can make the errors that you make at the beginning you're going to bring them with you yeah and exactly garbage in garbage out yeah and this will be more and more painful the more time goes on the more features you are then your application then for make a remediation and correct everything so okay so your van thank you for your help thank you for all the information you provided I think people will really like that and specifically people that are developing application and please contact your van can't go to Chino dot IO just to really understand what are the requirements so that you are developing your application right the first time okay man so thank you for your help and I wish you a nice day thanks for having me [Music] you