An Essential Primer for Medical Device Makers Looking to Serve the Multi-Billion Dollar Global EHR Market with Cloud Connectivity
Part Two – Key EHR impact areas for your medical device
In this three-part series we identify the opportunity for manufacturers to integrate their medical devices with EHR systems. Part One identified the opportunity, including market size potential and how medical device manufactures can build their case by delivering value to an EHR system provider. In Part Two, we present how their devices can address three key areas impacting EHR performance.
The growth of health data is explosive; the amount of data generated, collected and/or reported has risen by 878 percent since 2016, according to statistics compiled by Dell EMC.
The proliferation of medical devices will only increase the torrent of data, placing incredible challenges on EHR vendors tasked with evaluating that data first for its quality, accuracy usefulness and then for helping determine treatment plans and patient care.
According to the FDA, there are more than 190,000 different devices on the U.S. market. The FDA approves or clears about a dozen new or modified devices every single business day.
Adding to the data management challenge is the transition in healthcare delivery from a volume-based, fee-for-service payment model to a value-based care solution. Mandated through various federal legislative provisions, value-based care is transforming how healthcare professionals will use technology.
Under a value-based model of care, providers are incentivized with higher reimbursements for services based on reduced readmission rates, lower costs and better patient outcomes.
Succeeding with a value-based care model is data-intensive. It emphasizes large sets of quality-of-care metrics that track and report adverse events, patient engagement, treatment and patient health and wellness.
Value-based care means EHR vendors need to regularly adjust their systems to better enable providers to manage the cost and quality of their patients’ care. As EHR systems evolve, they will need to do more than collect and store data; they will help providers share data, interpret results and more accurately predict outcomes.
As a consequence, EHR vendors will seek processes and devices which can turn data-capture, cloud storage and connectivity into actionable insights at lower costs.
In this environment, medical device manufacturers will need to adjust their business models as well. Device quality and cost are only part of the value proposition. Manufacturers need to manage data – both physiological and demographic – with innovative visualization tools and analytics capabilities to be favorably positioned.
Integrated medical devices create new opportunities for healthcare providers, medical device companies and EHR vendors for scheduling, billing accuracy and improving patient care.
By collecting data in real time that’s shareable via the cloud to an EHR system, manufacturers can help providers:
- Document patient adherence to treatment regimens
- Reduce errors from manual data entry
- Identify medical issues before they become complications that lead to readmissions
In this capacity, devices can assist EHRs with better outcomes that boost reimbursement rates and reduce potential billing rejections from payers. These outcomes are becoming an increasingly important benefit to providers.
Workflow (Cloud and Interoperability)
As we stated, improving healthcare system workflow is mission critical for EHR vendors. The proliferating number of medical IoT devices presents new challenges and opportunities and requires new generations of EHR systems built for speed, flexibility and data.
The healthcare industry’s adoption of the cloud and interfaces that make data integration more efficient and user-friendly will accelerate in the coming decade. It will also increase demand for medical devices with cloud-based connectivity configured for new interoperability standards.
The Cloud: In the past, storage and security concerns slowed healthcare organizations’ migration to the cloud. This mindset is changing.
According to HIMSS, 65 percent of IT leaders from health systems, hospitals, and other large healthcare organizations currently utilize the cloud or cloud services at their facilities.
Migration to the cloud will increase the need for data-centric health environments requiring clinical application support, data hosting, data mining, data recovery, and backup.
EHR vendors are looking for solutions that can simplify the development and migration of cloud computing and control IT infrastructure costs.
Today’s health IT infrastructure systems are increasingly complex. Health IT departments are updating their systems to factor in hybrid cloud computing and edge computing (which decentralizes data transmission pathways) to manage the quick, efficient, secure flow of data from IoMT devices.
Medical device manufacturers with cloud-based platforms designed to meet the specific needs of different healthcare environments and specialties will be incredibly invaluable to EHR vendors. To succeed, manufacturers will need to deliver connectivity that’s scalable, flexible, intuitive, and accessible from multiple locations in real time.
Interoperability: The great promise of IoT to transform healthcare delivery rests on the ability to interconnect and share data, which is why internal and external data interoperability standards are so critical. Interoperability standards relate to the security, data transport, data format or structure, or the meanings of codes or terms.
How seamlessly your medical device will interoperate with an EHR system is a key consideration for EHR vendors defining the exchange, integration and interpretation of shared data from multiple sources including sensors and devices.
A promising next generation standard is Fast Healthcare Interoperability Resources (FHIR). HL7 FHIR is a content definition standard. Using standardized application programming interfaces (APIs), it replaces cumbersome document-based exchange with web-based browser technologies (e.g., HTTP or XML) that can share standardized device data.
What makes FHIR so intriguing is its ability to help clinicians securely and quickly exchange meaningful data from medical devices in a user-friendly way that’s similar to web experiences that consumers enjoy in other industries.
It holds the possibility of connecting disparate systems and making an application-based approach to interoperability and health information exchange a reality.
SMART on FHIR: Applications that use both SMART https://smarthealthit.org/ and FHIR are known as “SMART on FHIR.” SMART (Substitutable Medical Applications, Reusable Technologies) Health IT is an open, standards based technology platform.
SMART helps EHR systems and their applications authenticate and integrate. By standardizing these processes, health care providers can utilize more apps, and developers can write apps across healthcare system. An EHR system that supports the SMART standard, enables patients, doctors, and healthcare practitioners to draw on a library (gallery) of apps.
Here’s a good way to look at SMART on FHIR: “FHIR defines the structure of where data should live and how it should look. EHRs are responsible for filling that structure with actual patient data. SMART defines how third-party apps launch within an EHR, how to determine, which EHR user is interacting with the app, and what patient’s data is being accessed.”
It’s still in a development stage, but it’s rapidly gaining wider acceptance in organizations worldwide.
Any medical device manufacturer looking to enter the EHR market will need to be well versed in implementing the FHIR standard.
Compliance (FDA, HIPAA)
The growing number of IoMT devices and greater cloud connectivity can expose vulnerable hospital networks to serious security threats and privacy breaches. In part, that’s because the attack surface of the health information system expands when interconnected devices are permitted to connect to EHRs.
Device manufacturers working with EHR vendors will need to adhere to security requirements and conform to industry standards including:
FDA: Medical device systems must comply with strict FDA regulations in the electronic transfer, storage and conversion of medical device data to ensure connected medical device functions or parameters are not modified in any way.
Cloud-connected medical devices are classified by the FDA as a Medical Device Data Systems (MDDS). A MDDS does not modify the data or modify the display of the data, and it does not by itself control the functions or parameters of any other medical device.
Manufacturers must demonstrate they have conducted pre-market testing for vulnerabilities, patches, upgrades and updates to counter cybersecurity threats, address service reliability, and ensure data is protected if disaster recovery is needed.
HIPAA: As a connected medical device maker, you’ll need to ensure your device (and its EHR connectivity) enable physician practices and other providers to be HIPAA compliant. HIPAA (Health Insurance Portability and Accountability Act) and related regulations set strict guidelines to safeguard protected health information (PHI).
PHI is any information stored in an electronic format, which includes patient-specific information that is collected, maintained, or transmitted by medical devices. Healthcare providers are ultimately responsible for compliance, but medical device cloud platforms need to demonstrate how PHI is stored, managed, and accessed.
Industry Standards: Industry standards like ISO 13485:2016 include formal processes for design and change controls, traceability, risk management, verification and validation testing, and regulatory actions, which are relevant to the medical device industry. They support medical device manufacturers and help ensure consistent design, development, production, installation, and delivery of medical devices and software that are safe for their intended purpose.
In Part Three we provide actionable information with specific guidance for choosing a medical device connectivity platform and a partner that provides both technology expertise and regulatory know-how.