Health Record Connect

Medidata Health Record Connect는 EHR(전자의무기록) 데이터를 안전하고 컴플라이언스를 철저히 준수하는 방식으로 수집, 변환, 교환할 수 있도록 지원하는 EHR 통합 및 상호운용성 엔진입니다.

본 솔루션은 환자의 핵심 의료 정보에 대한 완전히 새로운 차원의 협업과 가시성을 제공합니다. 다각적인 연결성 접근 방식을 활용하는 Health Record Connect는 적절한 임상시험 기관과 환자로부터 정확한 데이터를 안전하게 수집 및 변환하여, 단일 사용자 경험(UX) 내에서 적합한 사용자에게 직관적으로 제공합니다.

Overview 보기

Medidata Health Record Connect 핵심 기능 및 이점

치료 옵션으로서의 임상 연구

많은 환자들에게 임상시험은 필수적인 치료 및 케어 옵션 중 하나입니다. 이를 '치료 옵션으로서의 임상 연구(CRAACO, Clinical Research as a Care Option)'라고 합니다. 일부 사례에서 중재적 임상시험(Interventional Clinical Trials)은 환자에게 남은 유일한 치료 대안이 되기도 합니다.환자의 평생에 걸친 헬스케어 데이터와 임상시험에 필요한 특정 데이터 세트 간의 경계가 점차 모호해지고 있습니다. 이에 따라 우리는 장기적으로 환자의 참여를 더 유도하고, 의료진이 임상적 의사결정을 내리는 데 필요한 가장 완전한 데이터를 확보할 수 있도록 더욱 스마트하고 효과적인 방안을 마련해야 합니다.

더 다양한 소스로부터 유입되는 복잡하고 다채로운 데이터를 관리하는 역량은 이제 선택이 아닌 필수입니다. 이는 단순한 비전이 아닙니다. 우리가 활용할 수 있는 데이터 생태계의 모든 요소를 동원하여, 연구와 헬스케어를 최대한 빠르고 안전하게 발전시키겠다는 환자들과의 약속입니다.

헬스케어와 임상 연구의 가교 역할

자세히 보기

Medidata Health Record Connect는 Rave Companion과 연동하여, 임상시험 기관이 Rave 서식을 작성할 때 이에 부합하는 EHR(전자의무기록) 데이터를 화면에 함께 띄워줍니다. 임상시험 서식에 환자의 기존 의료 기록에 존재하는 데이터가 필요할 때 이 기능을 활용하면 데이터 입력 속도를 획기적으로 단축할 수 있습니다. 이와 동시에, 시험 기관이 항상 완전한 정보를 바탕으로 정확한 임상적 의사결정을 내릴 수 있도록 지원합니다. 시험기관은 데이터에 대한 가시성을 상시 유지하며 데이터를 검토할 수 있고, 기관에서 서식을 직접 '저장'하기 전까지는 Rave로 어떠한 데이터도 전송되지 않으므로 안심하고 통제할 수 있습니다.

모든 헬스케어 시스템과의 연동성

각 임상시험 기관에 적합한 프로토콜이나 표준을 유연하게 적용하여 어떤 헬스케어 시스템과도 연동할 수 있습니다. 이를 통해 연구 초기 셋업(Startup) 시간을 단축하고 솔루션 도입률을 높입니다.

국가 및 지역 HIE 및 네트워크 활용 

보건의료정보교환(HIE) 네트워크를 통해 수많은 의료 기관 및 개인 병원과 즉각적인 연동(Out-of-the-box scalability)이 가능합니다. 매번 기관별로 일일이 개별 연동을 구축할 필요가 없어 확장성이 뛰어납니다. 

FHIR, CCDA, DICOM, HL7 글로벌 표준 지원

미국 내 의료 정보 교환에 널리 쓰이는 표준을 비롯하여, 업계에서 통용되는 모든 형태의 데이터 포맷과 프로토콜을 완벽하게 지원합니다. 

양방향 데이터 변환

데이터 통신 포맷 종류에 구애받지 않고, 임상시험 기관의 헬스케어 데이터를 모든 메디데이터(Medidata) 애플리케이션에서 유기적으로 활용할 수 있습니다.

종적 환자 인사이트 확보

다양한 소스로부터 데이터를 통합하므로, 해당 기관의 단편적인 기록을 넘어 환자의 전체 의료 이력(Full view)을 종합적으로 파악할 수 있습니다. 이를 통해 더욱 깊이 있고 풍부한 환자 인사이트를 도출합니다.

광범위한 치료 워크플로우 및 활용 사례 지원 

Medidata Health Record Connect는 Medidata Surgical Planning, 리얼월드 데이터(RWD) 통합 및 인사이트 도출, 그리고 Rave Companion을 활용한 임상시험 내 데이터 협업* 등 매우 광범위한 워크플로우와 활용 사례를 지원합니다. 

*참고: 중재적 임상시험(Interventional trials)에만 해당합니다. 모든 사용자는 데이터를 조회하는 의료 기관의 소속 직원이어야 하며, 항상 의사 또는 임상시험책임자(PI)의 감독 하에 연구에 등록된 환자의 안전성 정보(Safety events) 및 시험 결과 모니터링 업무를 수행해야 합니다. 

Featured Resource


Video Series: EHR-to-EDC에 대한 오해와 진실

Medidata Health Record Connect 및 Rave Companion과 같은 EHR-to-EDC 상호운용성 엔진이 어떻게 상호 작용하는지 영상으로 확인해 보세요. 임상시험 기관이 다른 시스템이나 문서에 흩어져 있는 근거 데이터를 Rave 서식에 얼마나 쉽고 빠르게 입력할 수 있는지 그 혁신적인 작동 방식을 보여드립니다. 

Series 보기
Video transcript: Sameer, building on the awesome mythbuster series that we did on health care data interoperability. Wanted to add this fireside chat to really zoom in on a couple key areas, you know, one being user experience and the second being access to data, what kind of data we have access to. You know, with Medidata's kind of paradigm shift to experiences, you know, the patient experience, the data experience, and the study experience. We also don't want to lose sight of zooming in on experiences around how sites use our technology and how healthcare data interoperability really fits in in general, which is something very, very important. I look at, as does metadata, always, look at healthcare data interoperability as something that just has to work. You shouldn't go to another place to use it. You shouldn't log in to yet another solution to leverage healthcare data interoperability. The experience around that needs to be seamless, you know, fitting directly in with exactly how sites are working. So share some of your perspective on experiences around health care data interoperability. Absolutely, Dan. I think, first off, you shouldn't build interoperability for interoperability's sake. It should accomplish your goal. And so it's important to build interoperability into the experiences and into the platform that users are already working at. It should empower their work, not not really change it per se, but make it better. Right? Make it more efficient. And in order to do that, you have to take a platform and experience centric approach. You need to think about how that's gonna fit within the existing users' workflows and not create more work for them. Right? No more additional point solutions, logins, right, different tools that they have to learn. It should be seamless for the user. Right? But they can start to gain the benefit of getting access to all this rich data that we can make available. Yeah. It's it's interesting. When I when we talk to people and I hear this every day and talking to sites as well as sponsors and CROs as well, it's we don't want yet another solution, yet another user interface to have to interact with. God forbid, yet another username and password or URL you have to go to. You know? So we look at EHR to EDC and the experience around that is how can we keep it simple for the sites? How can we let them work where they want to work? Whether if that's inside of Ray VDC, fantastic. If that's inside of Epic, let them work within Epic. But one experience, you know, we've seen some approaches where users log in to multiple things. They launch one app from their e EHR and then, you know, do some work there, then still have to come log in to the EDC. And to us, we want the experience to be one place. It's not one place you go to do everything that that you wanna do. The other cool thing about that is because we own the whole platform, now this gives us the unique opportunity to do some other cool things. You know, we can work with our EDC in a much more unique way than we could if we didn't own the old tech stack. We can work with our CTMS and other parts of the platform in a, you know, a unique way that traditionally you wouldn't be able to do. Talk a little bit about that from an experience perspective, some of the other things that we could do because we're part of the broader platform. Absolutely. So, you know, users aren't just just doing one thing, right, on our platform. They're doing a number of different things, and there's a number of different users that are doing things together, right, on a platform. I think it's really important to realize that. And so, you know, yes, users can leverage our technology now to make their data entry easier, right, to be more informed about the patient or make sure everyone that's working with the patient is more informed about the patient, making direct the the right decisions for that patient. But on top of that, sponsors can now look at which sites are, you know, leveraging our EHR solutions and make decisions about site monitoring based on that site selection, right, using our CTMS product. Sponsors can reduce their STV, right, because they know that these data are coming over electronically in some cases. Patients are on our platform. Right? We talk a lot about empowering the patient at Medidata. And and so now we can empower the patient with their own clinical data. Right? It's hard to build out patient registries and and help them make decisions about how they engage with with, you know, with with clinical trials and how they can use that as part for part of their treatment, you know, for for whatever they're going through. We can start building to your point. You mentioned Epic. Right? We can start building those experiences into the EHR as well so the user's staying in one location and not having to launch into multiple different solutions. Yeah. I think that's the key is meeting users where they wanna be. Exactly. You know, if you wanna work here, great. We're building an experience around, you know, that within the Ray platform. We're building an experience around site users that wanna work within their EHR. We're building an experience around patients who wanna interact with their EHR data directly in MyMedidata, which is our patient facing portal. Let's meet users where they wanna be, give them flexibility in their approach, give them flexibility in, you know, the the style of work and how they wanna work. But the key is one place to do everything, not logging into multiple systems and and. That's really the whole, you know, premise around EHR to EDC in the first place. You wanna eliminate the logging into ReadyVDC, going to look up data, coming back and typing it in, Going back to look it up, come back and typing in that swivel chair moment. So we also need to think about, you know, eliminating swivel chair moment even within solving the EHR to AVC problem. It's there's no sense having somebody log in to one, two, three, four different solutions just solve the problem. When we think about the flexibility and the meeting where users where they want to be, talk a little bit about what that means from an implementation perspective too because we're focused a lot on-site user experience, but we're also thinking a lot about IT experience within the hospitals. How hospital A wants us to connect to them and work is a lot different than hospital B. Hospital C, one hospital may want us to leverage FHIR. One hospital may want us to leverage CCDA type connectivity. Heck, some want us to create direct database connections or leverage older versions of HL7. At the end of the day, though, again, in the spirit of an experience, you want the IP experience to be, you know, seamless as well. So maybe talk a little bit about that. Well, Different types of connectivity. You know, you mentioned meeting users where they are. Right? And that's that's how we think about site connectivity as well, meeting the site where they are. And, you know, frankly, been doing interoperability, health care interoperability for a long time, and the one thing that I've learned is there's no one way. There's no one right answer. You know? And you have to build a platform that's flexible and that can work in the way that the site wants to work. And that makes interoperability and integration a whole lot easier, right, when you can build in that flexibility. So, yeah, FHIR is is amazing. Right? And it it truly is the future, and and it's something that we leverage on a daily basis. Right? Though so much of our work is FHIR based, but that's not the only way of getting to the data. Right? And so we have to be able to think about all the different ways that we can access data, bring those together, and then, you know, build an experience around that data so that the user can use it meaningfully to complete their work. Yeah. And it's not that one approach is better than the other, but having the flexibility and the variety and choice, you know, to present at sites and then being able to consult them on what the what we feel, hey. For this type of project, this is what we think is best. For this type of project, this is what we think is best. So just having that kind of collaboration with sites instead of, hey, we built it this way. This is how you have to do it. It is exactly right. Because there's times where fire's great. There's times where using CCDA are great. There's times where patient access and authorization to their data is great. You need to have a system that kind of presents all of those options and not forcing somebody into into one of them is what, know, we think is pretty important. Again, comes back to experience. How can you make the experience for site users the best possible? We think that we've nailed that with our flexibility of meeting them where they wanna be. We also think that we made the experience for IT a lot better. So now let's kind of move away from sites. You know, we went from sites to IT. Let's talk about the sponsors and ultimately what they want is the data. Yeah. You know, they want, you know, what what data can you access? You know, on day one, we we thought a lot about some of the low hanging fruit, vitals, lab results, things that, you know, were being filled out in CRS in large volume. And we've seen some lab CRS where it's, you know, forty, fifty different values that users are looking up and filling out that we have, you know, completely automated with a single click. And so that was low hanging fruit. But talking about some of the other types of data that we do get access to, lots of talk around this in the industry is, you know, it's just not the scalability in terms of who you can connect to, but the types of data that you can gain access to. And it's, you know, it's it's not just about moving for data from point a to point b. It's really being able to take that data and do something meaningful with it. Right? So, yeah, we have access or we can, you know, create access to a really large variety of data. Right? Not just labs and files, but you're talking meds and other things that are going you know, adverse events and just really what else is going on with the patient at that time and be able to bring it over in a way that can inform the entire team that's working around the patient to collaborate and make the best care decisions possible for that patient, right, on our platform. That's really that's moving beyond just transferring data from one place to another. Right? It's really empowering better decision making for the patient. Exactly. The patient treatment journey is different. When part of your treatment plan also includes a potential clinical trial, it's the level of collaboration and the level of keeping people aligned, keeping people informed that goes to a totally different level. Bridging that gap between healthcare collaboration, healthcare data and the clinical research side is something that's never been done. Again, patient treatment journeys are just so much different today than they were previously. A lot more sophistication to a lot of these paths. It's just super critical to keep everybody informed at every step in the process. That could be adverse events. That could just be how the patient's doing in general on a particular treatment and everything else in between. Is that correct? Yeah. Then again, we talked about experiences from the site. We talked about experiences from IT, experiences for the sponsors. Back on the data thing, the thing that I'm hearing a lot more questions about is STD. We're bringing in this data electronically. We were already trying to reduce our SDD. How can we think about it a little bit differently? And again, back to what you were saying earlier about being part of the platform, the other really cool thing that we can do is is like really track where data is coming from. The CRF could have fifty questions on who we know exactly which of those data points came from the EHR, which ones were manually typed in and so on. And we can provide that kind of transparency to update SDB strategies, what risk levels, different organizations you don't wanna take with with SDV. We can automate a lot of that stuff because we're part of one platform. Exactly. One experience, one platform. So it gives us a lot of lot of opportunity to do some pretty cool things. I'm glad we were able to get together. Thanks so much for the conversation. I want to do this more often because a lot of excitement around healthcare data interoperability. Some people narrow in on call it EHR to EDC. We love it. I know you love it. It's saying our customers love it and sites are begging for it. But with that excitement and that momentum starting to gain in our industry, there's still a lot of questions. There's lots of different approaches that people are doing and mocking one versus the other because they're all good. All of them are steps forward in automating this industry. With our focus on experience, we feel pretty confident in what we're doing from a scalability and experience perspective. Our customers are reacting very favorably to that. Let's keep these conversations going so we can update the industry on these important topics, what we're seeing, what we're hearing, and so on. Any closing thoughts for you? I mean, I think the cool opportunity that we have is to empower the entire experience, not just one part of it. And so that's what we're doing. And it it's it's been a pretty amazing journey so far. Looking forward to continuing it. So thank you for having me here. This has been my favorite topic. Right? So I love talking about it.
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FAQ

아닙니다. 본 솔루션은 즉각적인 확장성(Out-of-the-box scalability)을 제공하도록 설계되었습니다. 보건의료정보교환(HIE) 네트워크를 통해 수많은 의료 기관 및 개인 병원과 유기적으로 연동되므로, 기관별로 일일이 개별 연동을 구축할 필요가 없습니다. 각 임상시험 기관의 환경에 맞는 프로토콜이나 표준을 유연하게 활용하여 시스템을 연결하기 때문에, 연구 초기 셋업(Startup) 시간을 단축하고 솔루션 도입률을 대폭 높일 수 있습니다. 

Health Record Connect는 Rave Companion과 연동하여, 시험기관이 Rave 서식을 작성할 때 이에 부합하는 EHR 데이터를 화면에 함께 띄워줍니다. 이를 통해 환자의 의료 기록에 이미 존재하는 데이터를 기반으로 서식을 빠르게 채워 넣을 수 있어 데이터 입력 프로세스가 획기적으로 빨라집니다. 이와 동시에, EDC에 최종 제출되는 데이터에 대해서는 시험기관이 상시 검토하고 통제할 수 있도록 지원합니다. 

Rave Companion을 통한 임상시험 내 데이터 협업을 지원할 뿐만 아니라, 데이터 입력 단계를 넘어선 광범위한 워크플로우를 아우릅니다. 대표적으로Medidata Surgical Planning과 리얼월드 데이터(RWD) 통합 및 인사이트 도출 등이 포함되며, 이를 통해 전체 임상 개발 라이프사이클 전반에 걸쳐 솔루션의 활용 가치를 극대화합니다.

네, 제공합니다. Medidata는 고객사와 파트너사를 위해 자기 주도형 학습(Self-paced)과 강사 주도형 교육(Instructor-led)을 포함한 다양한 교육 옵션을 제공하고 있습니다. 현재 이용 가능한 교육 과정 및 관련 자료는 Medidata Global Education and Training 섹션에서 확인할 수 있습니다. 

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