Digital Health, Virtual-ICU, & Tele-Health Investments – Things to Contemplate & Red Flag Part Two
By: Tim Kuebelbeck, Chief Customer Officer at Ambient Clinical Analytics
Executive Brief
This is part two of a two-part series on digital health. The ‘Executive Brief’ portion of part two is somewhat of a repeat for those who did not read part one. I have read many articles on digital health, virtual-ICU, and tele-health investments that are centered on what to look for, and what the red flags are when evaluating platforms and solutions. Although many were helpful, I noticed they barely scratched the surface of the topic. After reading these articles, I was left with the impression that evaluating digital health is easy. As we all know, that’s not the case. Most of the articles I read were short, three or four-minute reads. They didn’t give any in-depth understanding, which is not surprising in today’s blog, sound bite, and meme-driven culture. The articles were absent of deep descriptions of what to look for in the digital health, virtual-ICU, and telehealth landscapes. Therefore, I decided to write a two-part series on digital health. In part one we covered seven major topics to consider when evaluating digital health solutions. In this second part we will discuss two more topics on digital health; ‘Build vs. Buy & Certification and Verification’. By themselves these topics are long and difficult to grasp, and thus required their own blog.
It is critical to note that digital health, virtual-ICU, and tele-health solutions are not just about rules, algorithms, connectivity, or video conferencing. It is much greater, and true virtual and digital solutions should provide a procedural and operational foundation for digital care delivery. Digital health platforms that offer a procedural and operational foundation for digital delivery of care will be more likely to deliver highly reliable healthcare. Highly reliable healthcare is something hospitals and health systems have been trying to achieve for decades.
During the pandemic, health systems rushed to implement standalone digital health and tele-health solutions and, in some cases, virtual-ICU solutions. Now health systems and hospitals are looking back at lessons learned and planning for connected platforms that cross the various stand-alone verticals of care. Comprehensive digital health from the hospital to the home will disrupt and redefine care delivery models in addition to changing the relationship between clinician, provider, personal caregiver, and patient, making digital health strategy the most important part of building a patient-centered healthcare system.
As organizations look to evaluate digital health, virtual-ICU, and tele-health solutions that cross verticals and disciplines, within a singular enterprise platform, there are several topics that executives should, and in some cases must consider for their healthcare organization. Many of these we covered in part one of this discussion. In part one and part two, we cover the things to consider in the build vs. buy debate. While you may not agree with all my evaluation points, this discussion will help you think critically about digital health and tele-health markets. If you're looking for an in-depth understanding of what to look for and what to watch out for, this is the right place for you.
Build vs. Buy
Build vs. Buy is a central topic to discuss for digital health and tele-health solutions. It is a debate we see healthcare providers and IT facing every day. The reality is when it comes to digital health or tele-health Build vs. Buy and Certification and Validation are linked to each other. They have an enormous bearing on your hospital or health systems performance and success utilizing digital health. The build vs. buy debate has ascended out of the “one solution to do it all” mentality and the “let’s reduce the number of solutions IT must manage” goal. Both are worthwhile and admirable objectives, but because health systems and hospitals aren’t always informed of the consequences of these decisions when it comes to digital health, these considerations become essential to discuss, interpret, and grasp.
‘We can build it in the EHR... The data required for real-time digital health or tele-health solutions is too difficult to extract and deliver from the EHR... Our EHR vendor says they can do this already... Our EHR vendor claims this is on the roadmap...’
I hear these statements all the time and many of these are a pretense to ‘I don’t want to implement and maintain another solution, or we already paid ½ Billion for our EHR, let’s try to leverage the EHR first.’ As an executive, you should be extremely wary of these excuses. If you read part one of this series on digital health, you would be even warier. Very few IT departments have the resources and employees with the proper skills to deliver a build your own solution in any functional way. Ultimately, if your hospital or health system is unable to deliver functioning digital health as described in part one of this series, your patients and clinicians end up paying the ultimate price. If after this warning you are still considering building a digital health platform, then the remaining portion of this article is a must-read for you.
Sometimes the IT leadership is playing these cards because they are truly wary of the dangers of innovation, and in some cases rightfully so. There are plenty of risky vendors in the digital health market today. But as the digital market is erupting as we begin easing away from the pandemic, this appears to be more of an excuse rather than a legitimate concern. Although the marketing hoopla was that Allscripts, Cerner, Epic, and Meditech (to a lesser extent) could do everything, they have proven over time that they can’t and never will do it all. Especially on the digital health and tele-health fronts. So, if your IT Department is telling you they can build this in the EHR, then a strong possibility exists that it might be time to evaluate your IT leadership before you make a major digital health decision. In the age of digital health and tele-health, your IT leadership must be able to evaluate the best path forward for digital health and tele-health without prejudice. In some cases, the EHR vendor might be the answer, but in all likeliness, it probably is not the best way to proceed for digital health.
There may be some instances where yes, digital health solutions can be built in the EHR, but the questions around ‘what’ will be built and how it will ‘function’ are two of the biggest ‘gotchas’. Understanding ease of adoption, ease of use, and functionality is an absolute requirement unless you want to risk adding additional strain and stress to your doctors and nurses. Forcing them to use ineffective solutions is painful for front-line healthcare workers, a waste of money for health systems, endangers patients, and never ends well. We have seen this far too often over the last decade as EHR deployments have become widespread. Fortunately, that mentality is starting to change rapidly.
If your IT department is adamant about building vs. buying, then take the time to do a thorough investigation including a demo and profound discussions with other hospitals (more than one) that have built something similar in the same EHR. A demo and discussion must include both clinical leadership and clinical front-line workers who use the system. Have deep conversations with users who are not the project sponsors to get an understanding and gauge the efficacy of the solution. A clear understanding of the clinical functionality and the use cases a proposed custom-built solution is capable of are crucial to solution positioning and future success in your organization. If after the demos and discussions are completed, you’re still interested in building the solution yourself, a full in-person or virtual site visit showing the solution in action is a must. Last, for a build decision, it is critical to create clinical and financial evaluations that document the functionality. Establish a full use case catalog that documents all functionality requirements to be delivered. Last build a total cost of ownership (TCO) model for development, deployment, and maintenance costs. Understanding the costs of build vs buy is critical. If your IT commits to building a digital health solution, a functionality catalog and financial TCO will help you hold everyone accountable for the delivery of all required elements, use cases, and keep the costs of a build within that budget.
Additionally, other elements must be considered in the build vs. buy discussion. First, is it a ‘One-Off’? The one-off discussion is tied to the functionality and TCO discussion and is vital to understand. Once the solution is built, who maintains the code, who fixes bugs, who continues to develop and test new custom code as different functionality requirements and innovation comes over the horizon? You or the EHR Vendor? What happens if you lose any of the key folks involved in the development? Does your organization have the capacity and rigor to document the code, and use six sigma quality management systems, like ISO 13485:2016, to maintain a quality product moving forward? The sum of considerations required to engage in building your own solution are complex and monumental, and often underestimated and taken too lightly.
Certification & Validation
What about certification and validation? A software application is regulated due to its intended use as a medical device, or any algorithm or clinical decision support that assists in medical decision making. Therefore, any purchase of a solution that fits the above description requires FDA or CE certification, dependent on what country you live in. This includes most digital health solutions. Many vendors are attempting to mask Software as a Medical Device (SaMD) solutions as consumer devices. Most vendors shy away from medical devices and many clinical algorithmic and decision support companies cloak their solutions as consumer devices, when in fact they are regulated medical devices. I see this over and over with hospitals making decisions for non-certified solutions and ending up with little or no improvements. This doesn’t just apply to vendors selling algorithms, it also applies to the EHR vendors including Epic, Cerner, Allscripts, & Meditech.
Many vendors who sell or have developed solutions fail to go through the appropriate FDA Clearance for the United States or CE Mark for EMEA. Furthermore, most don’t have the appropriate quality controls like ISO 13485:2016 specific to medical devices and SaMD companies. A great way to approach this is, to simply ask yourself if the solution you are buying is an FDA Class II cleared product? If not, what exposure does a non-FDA cleared solution give you if there is patient harm? Would you be willing to use non-FDA-approved physical medical devices on your patients? If not, why would you allow non-FDA digital health solutions to be used on your patients? Furthermore, regardless of buy vs built, without peer-reviewed published validation data required to achieve FDA clearance, you will never really know how well a physical medical device or SaMD is performing.
The importance of FDA Clearance for digital health platforms is illustrated clearly in a recent article in Digital Health – Modern Healthcare. The best description from that article on the importance of FDA Clearance was a quote from a digital officer at a major U.S. medical center. The quote reads, “I can’t imagine purchasing a piece of biomedical equipment without proof of validation,” said Dr. Edmondo Robinson, senior vice president and chief digital officer at Moffitt Cancer Center in Tampa, Florida. “I would never unleash that on a patient, right? It would be wrong. So why would I do that with digital tools?”1 Dr. Robinson’s point is a bullseye and should be taken very seriously. In other words, certain digital health solutions require FDA approvals.
This bears repeating because the stakes for patients are high, and patients are the ones who pay the ultimate price for vendors or health systems who take regulatory shortcuts or create and deploy ill-conceived solutions. As stated earlier in this white paper, there are multitudes of vendors ignoring the need for FDA approvals by masking their offerings as a consumer device, including all the major EHR vendors. This is indefensible and needs to change immediately. Many are correctly arguing that solutions without the appropriate FDA clearances are harming patients. One needs to look no further than America’s sepsis crisis and our decades-long poor performance in providing the appropriate treatment bundle. Today, many organizations are still relying on Nurses and Doctors for sepsis detection and manual-based paper processes to track care. Others utilize a sepsis detection algorithm and sepsis care propelled by non-FDA cleared solutions. Yet, many other healthcare organizations, that had previously built a sepsis detection algorithm, have turned it off. All of which is a major driver in why barely half of all septic patients in the United States receive the appropriate care bundle. Would delivering babies correctly half the time be acceptable? Obviously not, so why do we accept low performance from our digital health solutions? Many believe the lack of FDA enforcement is a short-term issue. One must assume that as digital health expands and unregulated solutions continue to cause more harm to patients, the Federal Government and the FDA will finally awaken to this evolving nightmare and begin enforcing and regulating all vendors appropriately, not just those who provide physical medical devices.
Achieving the U.S. Food and Drug Administration FDA Class II clearance for digital health and tele-health solutions show companies are designed for data collection, presentation, management, and storage of patient information, used in conjunction with independent patient bedside devices and Hospital Information Systems. In addition, the certification indications for use should be in clinical care of hospitalized adult, pediatric, and neonatal patients (Newborn, infant, child, and adolescent) with or at risk of critical illness. CE marking is a certification mark that indicates conformity with health, safety, and environmental protection standards for products sold within the European Economic Area (EEA). Similar to the FDA, CE Marking certification demonstrates platforms are capable of delivering safe digital health, virtual-ICU, and tele-health platforms. Depending on your global location, one or more of these certifications is necessary for digital health platforms.
Achievement of the ISO 13485:2016 certification, an internationally recognized quality standard specific to the medical device industry is just as important as the FDA and CE Mark approvals and certifications. The ISO 13485 standard is an internationally agreed standard that sets out the requirements for a quality management system specific to the medical device industry. ISO certification is incredibly important because it indicates that a company can apply six sigma quality standards to the business as a whole ensuring that every facet of the company including interactions with customers, not just the software, is managed from a quality perspective. By becoming ISO certified, a company demonstrates through time they have met the objectives of a rigorous standard of excellence, which is extremely important to health systems and will enhance their competitive advantage. From a build vs. buy perspective, functionality and use case deficits notwithstanding, managing the solution for quality over time in absence of ISO certification is probably the biggest long term gap a ‘build’ solution will have.
Certification or approval in all three certification bodies (FDA/CE/ISO) communicates a message to all potential provider healthcare partners that certified companies are world-class businesses capable of delivering value, quality, and long-lasting support. Digital health solutions that have a singular algorithm, that contain multiple algorithms, or clinical decision support that use AI, or ML to identify or assist in medical decision making, for critical or emergency illnesses, are FDA regulated and require FDA clearance in the United States.
Demonstrated solutions that have appropriate clearance, also have validation with meaningful measurable outcomes from the real world. ‘Moreover, few vendors have strong evidence that their solutions deliver the results they promise because their investors don’t require it, leaving it up to healthcare executives to separate fact from fiction.’2 If a digital health vendor can’t provide you with peer reviewed published validation data, then it is likely a very strong sign that you should be looking elsewhere for a solution. In addition, many companies are using bits and pieces of different published studies to market their solutions. While on the surface this may seem innocuous, you don’t really know until you read the studies. In reading studies from vendor claims, I have run across several companies that make claims that are contradicted in another study they make different claims from. One vendor even makes a claim on a study from their competitor. There are also a few vendors who cite studies in their marketing material but have failed to achieve FDA clearance. All three behaviors are suspect and should raise a red flag. Comprehending how the study was conducted and what it means is essential. With vendors who don’t have FDA clearance, be careful, and don’t just trust what the digital health vendor tells you. Validation is important, so read the studies vendors are quoting.
Summary
The three-year long Covid pandemic has unleashed rapid changes in healthcare and highlighted an enormous need for other technology advancements, primarily around digital health and managing acute patients from a distance. There are many considerations in selecting a vendor or partner for digital health ranging from build vs. buy, defined use cases, to competitive advantages. Although some of the things you need to consider are in part one of this blog, my hope is this has helped you appreciate why these considerations are essential to your selection process.
Executives owe it to themselves and the health system they work in to understand the digital health market and to mitigate risk around any selection processes. They should also recognize that even with mitigation they will likely take some sort of calculated risk. Most innovative digital health vendors are either startups or early-stage companies. Grasping selection concepts like clinical validation, certification, enhanced data access, sustainable business models, configurable solutions, etc... don’t necessarily guarantee a digital health vendors efficacy, health, or long-term success. However, if you have considered the evaluation points discussed above, it is likely you will choose a solid provider of digital health, virtual-ICU, or tele-health solutions that meets your organization’s needs.
If you haven’t embarked on a digital health journey yet, it is likely you will in the very near future. Making it necessary for both clinical and IT executives to assess some facet of digital health, virtual-ICU, or tele-health solutions. If you missed the material in our previous blog on the first seven topics to consider when evaluating digital health solutions, you can find that article here. I hope you enjoyed the ‘Build vs. Buy and Certification & Verification Part-Two’ of our Blog in this digital health series.
About Ambient Clinical Analytics
AWARE™ Patient View
Ambient has achieved FDA Class II Clearance, CE Marking, and ISO 13485:2016 Certification on the AWARE™ platform. AWARE™ provides tele-ICU or virtual-ICU remote patient monitoring along with predictive analytics. Combined with our novel clinical decision support tools we decrease provider fatigue, reduce errors, and save lives. Created by clinicians for clinicians, AWARE™ delivers portable real-time virtual ICU surveillance, situational awareness, and actionable information to the care team, improving outcomes and reducing costs in critical care and general inpatient areas.
AWARE’s (Ambient Warning and Response Evaluation) digital health solution is designed to provide bedside and remote patient monitoring using data visualization and clinical analytics. The AWARE™ Multi-Patient Viewer (MPV) and Single-Patient Viewer (SPV) allows all nurses and physicians to view a patient through the eyes of a intensivists regardless of their location. Acute and Critical care requires turning massive amounts of raw data into actionable knowledge. We make the data work for you.
An inability to process the required data is commonly known as information overload. Information overload frustrates clinicians and exposes patients to diagnostic errors and therapeutic harm. AWARE™ is different, it was built by intensivists at Mayo Clinic using principles of human factors engineering, gathering the data that’s important to critical care teams and displaying it in a way that minimizes cognitive load. AWARE™ is the gold standard for how smart clinical analytics and data visualization can improve communication, efficiency, situational awareness, and safety. Unlike any other system, AWARE™ shows you what you need to see, at the point of care in any acute settings, and in virtual ICU or virtual acute settings, organized the way an intensivist approaches their patients’ data.
AWARE Clinical Control Tower™ is a solution designed to provide a virtual ICU for AWARE™ Critical Care and Sepsis DART™ with centralized or decentralized remote patient monitoring and collaboration for physicians and nurses. Our Clinical Mesh Network™ with AWARE™ and Sepsis DART™ capabilities delivers to any location in a standardized format, eliminating EMR differences. Clinical Control Tower™ provides distributed tele-health, virtual ICU and remote patient monitoring within your system and with contracted facilities.
Whether deployed in an ICU or as a virtual ICU solution, the AWARE™ enterprise class family of solutions including Sepsis DART, AWARE Critical Care, and Clinical Control Tower all help you approach your patients in an efficient, more effective, informed, and organized fashion while decreasing provider fatigue, reducing errors, and saving lives. Created by clinicians for clinicians, AWARE™ delivers real-time surveillance, situational awareness, and actionable information to the care team, improving outcomes and reducing costs in critical care and general inpatient areas.
Ambient’s predictive analytics and advanced clinical decision support tools is clinically validated to reduces errors, improve patient outcomes, reduce the cost of care, and deliver best-care practices for any acute care setting from the ICU to the home. AWARE’s predictive analytics system provides a “smart view” via data visualization of Electronic Health Record data that reduces the risk of medical errors and improves patient outcomes with high reliability healthcare. It works with your EMR and bedside monitors to present only relevant information for care delivery.
For detailed information on Ambient Clinical Analytics and Virtual ICU or Remote Patient Monitoring solutions for your hospital or health system, or for our published studies on AWARE™ please contact tim.kuebelbeck@ambientclinical.com.
About Ambient Clinical Analytics - As an industry leader, Ambient is supporting leading healthcare systems and has done so since its founding in 2013. Our solutions are designed by clinicians to be easy-to-use by every caregiver in your organization and are configured to be up and running rapidly. We are trusted by a community of high-performing healthcare providers across the United States. Our solutions are powerful real-time point-of-care and remote healthcare platforms designed to deliver life-saving solutions using data visualization, communication, and analytics based clinical decision support.
1 Digital Health – Modern Healthcare, Digital tools give providers lots of data, but can clinicians trust it? Brady, Michael, February 08, 2022
2 Digital Health – Modern Healthcare, Digital tools give providers lots of data, but can clinicians trust it? Brady, Michael, February 08, 2022
Executive Brief
This is part two of a two-part series on digital health. The ‘Executive Brief’ portion of part two is somewhat of a repeat for those who did not read part one. I have read many articles on digital health, virtual-ICU, and tele-health investments that are centered on what to look for, and what the red flags are when evaluating platforms and solutions. Although many were helpful, I noticed they barely scratched the surface of the topic. After reading these articles, I was left with the impression that evaluating digital health is easy. As we all know, that’s not the case. Most of the articles I read were short, three or four-minute reads. They didn’t give any in-depth understanding, which is not surprising in today’s blog, sound bite, and meme-driven culture. The articles were absent of deep descriptions of what to look for in the digital health, virtual-ICU, and telehealth landscapes. Therefore, I decided to write a two-part series on digital health. In part one we covered seven major topics to consider when evaluating digital health solutions. In this second part we will discuss two more topics on digital health; ‘Build vs. Buy & Certification and Verification’. By themselves these topics are long and difficult to grasp, and thus required their own blog.
It is critical to note that digital health, virtual-ICU, and tele-health solutions are not just about rules, algorithms, connectivity, or video conferencing. It is much greater, and true virtual and digital solutions should provide a procedural and operational foundation for digital care delivery. Digital health platforms that offer a procedural and operational foundation for digital delivery of care will be more likely to deliver highly reliable healthcare. Highly reliable healthcare is something hospitals and health systems have been trying to achieve for decades.
During the pandemic, health systems rushed to implement standalone digital health and tele-health solutions and, in some cases, virtual-ICU solutions. Now health systems and hospitals are looking back at lessons learned and planning for connected platforms that cross the various stand-alone verticals of care. Comprehensive digital health from the hospital to the home will disrupt and redefine care delivery models in addition to changing the relationship between clinician, provider, personal caregiver, and patient, making digital health strategy the most important part of building a patient-centered healthcare system.
As organizations look to evaluate digital health, virtual-ICU, and tele-health solutions that cross verticals and disciplines, within a singular enterprise platform, there are several topics that executives should, and in some cases must consider for their healthcare organization. Many of these we covered in part one of this discussion. In part one and part two, we cover the things to consider in the build vs. buy debate. While you may not agree with all my evaluation points, this discussion will help you think critically about digital health and tele-health markets. If you're looking for an in-depth understanding of what to look for and what to watch out for, this is the right place for you.
Build vs. Buy
Build vs. Buy is a central topic to discuss for digital health and tele-health solutions. It is a debate we see healthcare providers and IT facing every day. The reality is when it comes to digital health or tele-health Build vs. Buy and Certification and Validation are linked to each other. They have an enormous bearing on your hospital or health systems performance and success utilizing digital health. The build vs. buy debate has ascended out of the “one solution to do it all” mentality and the “let’s reduce the number of solutions IT must manage” goal. Both are worthwhile and admirable objectives, but because health systems and hospitals aren’t always informed of the consequences of these decisions when it comes to digital health, these considerations become essential to discuss, interpret, and grasp.
‘We can build it in the EHR... The data required for real-time digital health or tele-health solutions is too difficult to extract and deliver from the EHR... Our EHR vendor says they can do this already... Our EHR vendor claims this is on the roadmap...’
I hear these statements all the time and many of these are a pretense to ‘I don’t want to implement and maintain another solution, or we already paid ½ Billion for our EHR, let’s try to leverage the EHR first.’ As an executive, you should be extremely wary of these excuses. If you read part one of this series on digital health, you would be even warier. Very few IT departments have the resources and employees with the proper skills to deliver a build your own solution in any functional way. Ultimately, if your hospital or health system is unable to deliver functioning digital health as described in part one of this series, your patients and clinicians end up paying the ultimate price. If after this warning you are still considering building a digital health platform, then the remaining portion of this article is a must-read for you.
Sometimes the IT leadership is playing these cards because they are truly wary of the dangers of innovation, and in some cases rightfully so. There are plenty of risky vendors in the digital health market today. But as the digital market is erupting as we begin easing away from the pandemic, this appears to be more of an excuse rather than a legitimate concern. Although the marketing hoopla was that Allscripts, Cerner, Epic, and Meditech (to a lesser extent) could do everything, they have proven over time that they can’t and never will do it all. Especially on the digital health and tele-health fronts. So, if your IT Department is telling you they can build this in the EHR, then a strong possibility exists that it might be time to evaluate your IT leadership before you make a major digital health decision. In the age of digital health and tele-health, your IT leadership must be able to evaluate the best path forward for digital health and tele-health without prejudice. In some cases, the EHR vendor might be the answer, but in all likeliness, it probably is not the best way to proceed for digital health.
There may be some instances where yes, digital health solutions can be built in the EHR, but the questions around ‘what’ will be built and how it will ‘function’ are two of the biggest ‘gotchas’. Understanding ease of adoption, ease of use, and functionality is an absolute requirement unless you want to risk adding additional strain and stress to your doctors and nurses. Forcing them to use ineffective solutions is painful for front-line healthcare workers, a waste of money for health systems, endangers patients, and never ends well. We have seen this far too often over the last decade as EHR deployments have become widespread. Fortunately, that mentality is starting to change rapidly.
If your IT department is adamant about building vs. buying, then take the time to do a thorough investigation including a demo and profound discussions with other hospitals (more than one) that have built something similar in the same EHR. A demo and discussion must include both clinical leadership and clinical front-line workers who use the system. Have deep conversations with users who are not the project sponsors to get an understanding and gauge the efficacy of the solution. A clear understanding of the clinical functionality and the use cases a proposed custom-built solution is capable of are crucial to solution positioning and future success in your organization. If after the demos and discussions are completed, you’re still interested in building the solution yourself, a full in-person or virtual site visit showing the solution in action is a must. Last, for a build decision, it is critical to create clinical and financial evaluations that document the functionality. Establish a full use case catalog that documents all functionality requirements to be delivered. Last build a total cost of ownership (TCO) model for development, deployment, and maintenance costs. Understanding the costs of build vs buy is critical. If your IT commits to building a digital health solution, a functionality catalog and financial TCO will help you hold everyone accountable for the delivery of all required elements, use cases, and keep the costs of a build within that budget.
Additionally, other elements must be considered in the build vs. buy discussion. First, is it a ‘One-Off’? The one-off discussion is tied to the functionality and TCO discussion and is vital to understand. Once the solution is built, who maintains the code, who fixes bugs, who continues to develop and test new custom code as different functionality requirements and innovation comes over the horizon? You or the EHR Vendor? What happens if you lose any of the key folks involved in the development? Does your organization have the capacity and rigor to document the code, and use six sigma quality management systems, like ISO 13485:2016, to maintain a quality product moving forward? The sum of considerations required to engage in building your own solution are complex and monumental, and often underestimated and taken too lightly.
Certification & Validation
What about certification and validation? A software application is regulated due to its intended use as a medical device, or any algorithm or clinical decision support that assists in medical decision making. Therefore, any purchase of a solution that fits the above description requires FDA or CE certification, dependent on what country you live in. This includes most digital health solutions. Many vendors are attempting to mask Software as a Medical Device (SaMD) solutions as consumer devices. Most vendors shy away from medical devices and many clinical algorithmic and decision support companies cloak their solutions as consumer devices, when in fact they are regulated medical devices. I see this over and over with hospitals making decisions for non-certified solutions and ending up with little or no improvements. This doesn’t just apply to vendors selling algorithms, it also applies to the EHR vendors including Epic, Cerner, Allscripts, & Meditech.
Many vendors who sell or have developed solutions fail to go through the appropriate FDA Clearance for the United States or CE Mark for EMEA. Furthermore, most don’t have the appropriate quality controls like ISO 13485:2016 specific to medical devices and SaMD companies. A great way to approach this is, to simply ask yourself if the solution you are buying is an FDA Class II cleared product? If not, what exposure does a non-FDA cleared solution give you if there is patient harm? Would you be willing to use non-FDA-approved physical medical devices on your patients? If not, why would you allow non-FDA digital health solutions to be used on your patients? Furthermore, regardless of buy vs built, without peer-reviewed published validation data required to achieve FDA clearance, you will never really know how well a physical medical device or SaMD is performing.
The importance of FDA Clearance for digital health platforms is illustrated clearly in a recent article in Digital Health – Modern Healthcare. The best description from that article on the importance of FDA Clearance was a quote from a digital officer at a major U.S. medical center. The quote reads, “I can’t imagine purchasing a piece of biomedical equipment without proof of validation,” said Dr. Edmondo Robinson, senior vice president and chief digital officer at Moffitt Cancer Center in Tampa, Florida. “I would never unleash that on a patient, right? It would be wrong. So why would I do that with digital tools?”1 Dr. Robinson’s point is a bullseye and should be taken very seriously. In other words, certain digital health solutions require FDA approvals.
This bears repeating because the stakes for patients are high, and patients are the ones who pay the ultimate price for vendors or health systems who take regulatory shortcuts or create and deploy ill-conceived solutions. As stated earlier in this white paper, there are multitudes of vendors ignoring the need for FDA approvals by masking their offerings as a consumer device, including all the major EHR vendors. This is indefensible and needs to change immediately. Many are correctly arguing that solutions without the appropriate FDA clearances are harming patients. One needs to look no further than America’s sepsis crisis and our decades-long poor performance in providing the appropriate treatment bundle. Today, many organizations are still relying on Nurses and Doctors for sepsis detection and manual-based paper processes to track care. Others utilize a sepsis detection algorithm and sepsis care propelled by non-FDA cleared solutions. Yet, many other healthcare organizations, that had previously built a sepsis detection algorithm, have turned it off. All of which is a major driver in why barely half of all septic patients in the United States receive the appropriate care bundle. Would delivering babies correctly half the time be acceptable? Obviously not, so why do we accept low performance from our digital health solutions? Many believe the lack of FDA enforcement is a short-term issue. One must assume that as digital health expands and unregulated solutions continue to cause more harm to patients, the Federal Government and the FDA will finally awaken to this evolving nightmare and begin enforcing and regulating all vendors appropriately, not just those who provide physical medical devices.
Achieving the U.S. Food and Drug Administration FDA Class II clearance for digital health and tele-health solutions show companies are designed for data collection, presentation, management, and storage of patient information, used in conjunction with independent patient bedside devices and Hospital Information Systems. In addition, the certification indications for use should be in clinical care of hospitalized adult, pediatric, and neonatal patients (Newborn, infant, child, and adolescent) with or at risk of critical illness. CE marking is a certification mark that indicates conformity with health, safety, and environmental protection standards for products sold within the European Economic Area (EEA). Similar to the FDA, CE Marking certification demonstrates platforms are capable of delivering safe digital health, virtual-ICU, and tele-health platforms. Depending on your global location, one or more of these certifications is necessary for digital health platforms.
Achievement of the ISO 13485:2016 certification, an internationally recognized quality standard specific to the medical device industry is just as important as the FDA and CE Mark approvals and certifications. The ISO 13485 standard is an internationally agreed standard that sets out the requirements for a quality management system specific to the medical device industry. ISO certification is incredibly important because it indicates that a company can apply six sigma quality standards to the business as a whole ensuring that every facet of the company including interactions with customers, not just the software, is managed from a quality perspective. By becoming ISO certified, a company demonstrates through time they have met the objectives of a rigorous standard of excellence, which is extremely important to health systems and will enhance their competitive advantage. From a build vs. buy perspective, functionality and use case deficits notwithstanding, managing the solution for quality over time in absence of ISO certification is probably the biggest long term gap a ‘build’ solution will have.
Certification or approval in all three certification bodies (FDA/CE/ISO) communicates a message to all potential provider healthcare partners that certified companies are world-class businesses capable of delivering value, quality, and long-lasting support. Digital health solutions that have a singular algorithm, that contain multiple algorithms, or clinical decision support that use AI, or ML to identify or assist in medical decision making, for critical or emergency illnesses, are FDA regulated and require FDA clearance in the United States.
Demonstrated solutions that have appropriate clearance, also have validation with meaningful measurable outcomes from the real world. ‘Moreover, few vendors have strong evidence that their solutions deliver the results they promise because their investors don’t require it, leaving it up to healthcare executives to separate fact from fiction.’2 If a digital health vendor can’t provide you with peer reviewed published validation data, then it is likely a very strong sign that you should be looking elsewhere for a solution. In addition, many companies are using bits and pieces of different published studies to market their solutions. While on the surface this may seem innocuous, you don’t really know until you read the studies. In reading studies from vendor claims, I have run across several companies that make claims that are contradicted in another study they make different claims from. One vendor even makes a claim on a study from their competitor. There are also a few vendors who cite studies in their marketing material but have failed to achieve FDA clearance. All three behaviors are suspect and should raise a red flag. Comprehending how the study was conducted and what it means is essential. With vendors who don’t have FDA clearance, be careful, and don’t just trust what the digital health vendor tells you. Validation is important, so read the studies vendors are quoting.
Summary
The three-year long Covid pandemic has unleashed rapid changes in healthcare and highlighted an enormous need for other technology advancements, primarily around digital health and managing acute patients from a distance. There are many considerations in selecting a vendor or partner for digital health ranging from build vs. buy, defined use cases, to competitive advantages. Although some of the things you need to consider are in part one of this blog, my hope is this has helped you appreciate why these considerations are essential to your selection process.
Executives owe it to themselves and the health system they work in to understand the digital health market and to mitigate risk around any selection processes. They should also recognize that even with mitigation they will likely take some sort of calculated risk. Most innovative digital health vendors are either startups or early-stage companies. Grasping selection concepts like clinical validation, certification, enhanced data access, sustainable business models, configurable solutions, etc... don’t necessarily guarantee a digital health vendors efficacy, health, or long-term success. However, if you have considered the evaluation points discussed above, it is likely you will choose a solid provider of digital health, virtual-ICU, or tele-health solutions that meets your organization’s needs.
If you haven’t embarked on a digital health journey yet, it is likely you will in the very near future. Making it necessary for both clinical and IT executives to assess some facet of digital health, virtual-ICU, or tele-health solutions. If you missed the material in our previous blog on the first seven topics to consider when evaluating digital health solutions, you can find that article here. I hope you enjoyed the ‘Build vs. Buy and Certification & Verification Part-Two’ of our Blog in this digital health series.
About Ambient Clinical Analytics
AWARE™ Patient View
Ambient has achieved FDA Class II Clearance, CE Marking, and ISO 13485:2016 Certification on the AWARE™ platform. AWARE™ provides tele-ICU or virtual-ICU remote patient monitoring along with predictive analytics. Combined with our novel clinical decision support tools we decrease provider fatigue, reduce errors, and save lives. Created by clinicians for clinicians, AWARE™ delivers portable real-time virtual ICU surveillance, situational awareness, and actionable information to the care team, improving outcomes and reducing costs in critical care and general inpatient areas.
AWARE’s (Ambient Warning and Response Evaluation) digital health solution is designed to provide bedside and remote patient monitoring using data visualization and clinical analytics. The AWARE™ Multi-Patient Viewer (MPV) and Single-Patient Viewer (SPV) allows all nurses and physicians to view a patient through the eyes of a intensivists regardless of their location. Acute and Critical care requires turning massive amounts of raw data into actionable knowledge. We make the data work for you.
An inability to process the required data is commonly known as information overload. Information overload frustrates clinicians and exposes patients to diagnostic errors and therapeutic harm. AWARE™ is different, it was built by intensivists at Mayo Clinic using principles of human factors engineering, gathering the data that’s important to critical care teams and displaying it in a way that minimizes cognitive load. AWARE™ is the gold standard for how smart clinical analytics and data visualization can improve communication, efficiency, situational awareness, and safety. Unlike any other system, AWARE™ shows you what you need to see, at the point of care in any acute settings, and in virtual ICU or virtual acute settings, organized the way an intensivist approaches their patients’ data.
AWARE Clinical Control Tower™ is a solution designed to provide a virtual ICU for AWARE™ Critical Care and Sepsis DART™ with centralized or decentralized remote patient monitoring and collaboration for physicians and nurses. Our Clinical Mesh Network™ with AWARE™ and Sepsis DART™ capabilities delivers to any location in a standardized format, eliminating EMR differences. Clinical Control Tower™ provides distributed tele-health, virtual ICU and remote patient monitoring within your system and with contracted facilities.
Whether deployed in an ICU or as a virtual ICU solution, the AWARE™ enterprise class family of solutions including Sepsis DART, AWARE Critical Care, and Clinical Control Tower all help you approach your patients in an efficient, more effective, informed, and organized fashion while decreasing provider fatigue, reducing errors, and saving lives. Created by clinicians for clinicians, AWARE™ delivers real-time surveillance, situational awareness, and actionable information to the care team, improving outcomes and reducing costs in critical care and general inpatient areas.
Ambient’s predictive analytics and advanced clinical decision support tools is clinically validated to reduces errors, improve patient outcomes, reduce the cost of care, and deliver best-care practices for any acute care setting from the ICU to the home. AWARE’s predictive analytics system provides a “smart view” via data visualization of Electronic Health Record data that reduces the risk of medical errors and improves patient outcomes with high reliability healthcare. It works with your EMR and bedside monitors to present only relevant information for care delivery.
For detailed information on Ambient Clinical Analytics and Virtual ICU or Remote Patient Monitoring solutions for your hospital or health system, or for our published studies on AWARE™ please contact tim.kuebelbeck@ambientclinical.com.
About Ambient Clinical Analytics - As an industry leader, Ambient is supporting leading healthcare systems and has done so since its founding in 2013. Our solutions are designed by clinicians to be easy-to-use by every caregiver in your organization and are configured to be up and running rapidly. We are trusted by a community of high-performing healthcare providers across the United States. Our solutions are powerful real-time point-of-care and remote healthcare platforms designed to deliver life-saving solutions using data visualization, communication, and analytics based clinical decision support.
1 Digital Health – Modern Healthcare, Digital tools give providers lots of data, but can clinicians trust it? Brady, Michael, February 08, 2022
2 Digital Health – Modern Healthcare, Digital tools give providers lots of data, but can clinicians trust it? Brady, Michael, February 08, 2022