Shane McNamee, Chief Medical Information Officer, Smile CDR08.01.22
The healthcare industry has certainly been seeing a shift in the way it operates. Over the past decade, we’ve seen a transformation in the way healthcare providers, patients and other industry players interact with healthcare data.
As this transformation continues to evolve, it will be important for the medical device manufacturing industry to stay abreast of how it can best integrate into a new world of interoperability. Open healthcare data standards’ integration in medical devices is a unique element of the interoperability puzzle and one of the most important pieces in ensuring improved patient outcomes.
With new CMS regulations, the healthcare industry as a whole will be focused on ensuring the interoperability of all systems. Utilizing open healthcare data standards to ingest, normalize and then integrate medical device data and other healthcare information into a comprehensive data ecosystem is a win-win.
This data can then be integrated to any number of downstream healthcare applications used in patient care. Additionally, the data harmonization and integration approach improves patient care safety profiles and at the same time decreases the risk of patient safety events due to missed or inaccurate data, key measures often sought by a healthcare system focused improving the quality of care
Furthermore, device manufacturers can apply this data standard to their devices as a pre-integration strategy to ensure seamless data interoperability. As the FHIR data standard is now increasingly required to meet regulatory guidelines, its use future proofs the investment of medical device manufacturers and drastically increases the speed and quality of data integrations into healthcare provider systems.
Looking into the future, streaming fully integrated, standards-compliant medical device data is driving numerous innovations. Having the data available through fully integrated, intelligent data hubs would markedly improve safety profiles and decrease provider burden.
For example, at Smile CDR we place a tremendous emphasis on security and trust. Our recent attainment of the ISO 13485:2016 Quality Management System Software as a Medical Device (SaMD) certification for our namesake platform along with being one of the first companies to be HITRUST CSF certified, the gold standard in terms of healthcare/HIPAA certifications for organizations that store or process personal health information, were critical to our strategy to support medical device data integration and streaming. Ensuring partners place a high priority on data safety provides customers with the assurance that their information is being appropriately managed.
Shane McNamee M.D. is a Clinical Solutions Architect and a board-certified Physical Medicine & Rehabilitation Physician (PM&R) and currently serves as the Chief Medical Information Officer (CMIO) at Smile CDR. McNamee also serves as the Executive Director for OMG sponsored BPM+ Health Community and is a board member in IHE USA.
As this transformation continues to evolve, it will be important for the medical device manufacturing industry to stay abreast of how it can best integrate into a new world of interoperability. Open healthcare data standards’ integration in medical devices is a unique element of the interoperability puzzle and one of the most important pieces in ensuring improved patient outcomes.
How Does Interoperability Impact Medical Device Manufacturing?
Medical devices generate critical data about the health and wellbeing of patients. Yet, until recently, this data has not been readily available to help improve patient outcomes. Seamlessly integrating this data with other patient data sources directly into the workflows of doctors, nurses and other healthcare providers should be a key goal for any medical device manufacturing company and an important attribute when evaluating potential partners or vendors.With new CMS regulations, the healthcare industry as a whole will be focused on ensuring the interoperability of all systems. Utilizing open healthcare data standards to ingest, normalize and then integrate medical device data and other healthcare information into a comprehensive data ecosystem is a win-win.
This data can then be integrated to any number of downstream healthcare applications used in patient care. Additionally, the data harmonization and integration approach improves patient care safety profiles and at the same time decreases the risk of patient safety events due to missed or inaccurate data, key measures often sought by a healthcare system focused improving the quality of care
How Can Open Healthcare Standards Advance the Future of Medical Devices in Healthcare Settings?
Open standards data fabrics allow medical device manufacturers to begin taking advantage of plug and play Fast Healthcare Interoperability Resources (FHIR) application programming interface integration capabilities. The FHIR data standard has the ability to allow medical device manufacturers to stream and integrate existing data into modern healthcare data ecosystems.Furthermore, device manufacturers can apply this data standard to their devices as a pre-integration strategy to ensure seamless data interoperability. As the FHIR data standard is now increasingly required to meet regulatory guidelines, its use future proofs the investment of medical device manufacturers and drastically increases the speed and quality of data integrations into healthcare provider systems.
How Is the Industry Improving to Transform Medical Device Manufacturing?
With the current gaps in the industry surrounding data standardization and integration into existing clinical workflows, open standards data fabrics can provide a solution and become an advantage for medical device manufacturers.Looking into the future, streaming fully integrated, standards-compliant medical device data is driving numerous innovations. Having the data available through fully integrated, intelligent data hubs would markedly improve safety profiles and decrease provider burden.
How Can We Ensure Data Safety with The Introduction of Interoperability?
With the benefit of data hubs also comes the threat of cyber-attacks. In this industry shift, manufacturers should work with companies that keep up with security standards as they are increasingly important in a landscape of cyber-attacks focused on healthcare provider organizations. Security standards provide the necessary protection and peace of mind for healthcare customers.For example, at Smile CDR we place a tremendous emphasis on security and trust. Our recent attainment of the ISO 13485:2016 Quality Management System Software as a Medical Device (SaMD) certification for our namesake platform along with being one of the first companies to be HITRUST CSF certified, the gold standard in terms of healthcare/HIPAA certifications for organizations that store or process personal health information, were critical to our strategy to support medical device data integration and streaming. Ensuring partners place a high priority on data safety provides customers with the assurance that their information is being appropriately managed.
Shane McNamee M.D. is a Clinical Solutions Architect and a board-certified Physical Medicine & Rehabilitation Physician (PM&R) and currently serves as the Chief Medical Information Officer (CMIO) at Smile CDR. McNamee also serves as the Executive Director for OMG sponsored BPM+ Health Community and is a board member in IHE USA.