HEALTHCARE INTEROPERABILITY

Medical Device Interoperability

Interoperability plays a vital role in the modern healthcare system.

Interoperability in healthcare is the ability for various healthcare information technology (HIT) to exchange, interpret, and use data cohesively.

(or)

Interoperability in healthcare is the process that enables medical devices and other systems to interact with each other in real-time.

Since the?American Recovery and Reinvestment Act (ARRA)?was enacted in 2009, healthcare providers have been forced to switch from paper to electronic health records. Among many other industry-changing factors, ARRA outlined expectations for health information technology (HIT) to electronically exchange data.?

This has been a major development in healthcare in recent years and is arguably the leading force pushing the industry towards interoperability today.

But Cybersecurity concerns rise along with the increasing interoperability of medical devices.

Interoperability Important in Healthcare:-

The largest medical device companies have long appreciated the importance of medical device interoperability. In practice, this opportunity offers the following benefits:

• Better data management.?When it comes to data management, there is no better solution than a system that puts data on virtual shelves automatically. Depending on how your devices and systems are programmed, you can more effectively manage your data as required by your hospital.
• Error reduction.?When the data is automatically transferred from a wearable or implanted devices into a?patient’s electronic medical record (EMR), you eliminate the risk of human data entry errors, and the doctors get the opportunity to work with real-time information on the patient’s health so they can make fully informed decisions.
• Saves time.?When medical devices and systems are interconnected and interoperable, doctors can save time that was spent on data transfer and analysis and focus on caring for patients. A lot of time and effort can also be saved with the help of remote monitoring features wherein the medical device, the EHR system, and the doctor’s application are connected and able to interoperate and send and receive instant alerts on a patient’s health conditions.

Benefits of Healthcare Interoperability:-

Reduces Healthcare Cost & Boosts Productivity

Healthcare interoperability may boost productivity while reducing costs and mistakes by facilitating the exchange of vital health information across?medical practices, payers, laboratories, suppliers, and public health registries. This not only significantly improves the lives of healthcare workers and professionals, but it also helps patients have a better overall experience.?

Quality of Care

Most patients receive care from a series of clinics, independent practices,?and hospitals. Those individual interactions make up the entirety of their medical history, otherwise known as the Continuum of Care. This history documents past symptoms, procedures, allergies, complications, etc. Not having access to all of those data points due to the lack of integrated?healthcare IT systems?is dangerous at most and at the least extremely inconvenient for the patient. Full visibility and access to patient data for both the healthcare institution and the patient is the primary benefit of interoperability.

Efficiency

By having real-time results at their fingertips medical practices can cut down on repetitive tasks and drastically increase margins by treating more patients and increasing the quality of care they receive. Patients will have more control over their own data, removing a significant amount of that administrative burden. The remaining administrative and clinical functions will be streamlined due to accurate data and insights.?

Reduced Physician Burnout

Healthcare EHR adoption has raised executive and physician burnout, unlike other industries where the digital revolution has reduced administrative and physician tiredness. Increasing regulatory compliance requirements, a lack of interoperability, and the sheer amount of software solutions have added to the workload for physicians and administrators alike. Reduced paperwork for employees and eliminating the need for manual data entry are significant advantages of healthcare interoperability.?

Promotes Patient Education

Interoperability in healthcare can also encourage patient engagement and patient education. Consider the primary care physician who may provide a patient who has just received diabetes diagnosis training resources via the patient portal. This activity would be labor-intensive and laborious without interoperability between the educational system and the electronic health records.?

Financial Incentives & Reimbursements

Meaningful Use, which offered incentives to practices that adopted?EHR electronic health records?set the tone for interoperability between systems and its alignment with financial incentives. This will continue to play a major role in future developments in value-based care, such as?MIPS/MACRA,?amplifying the relationship between patient outcomes and financial performance.

Medical Device Interoperability Standards:-

When it comes to medical device interoperability, the core standard which applies to the field is the ANSI/AAMI/ UL 2800-1: 2019—Standard for Safety for Medical Device Interoperability.

• AAMI/ANSI/UL 2800-1 (2022): Standard for Medical Device Interoperability
• ANSI/AAMI/UL 2800-1-1:2022 - Standard for Risk Concerns for Interoperable Medical Products
• ANSI/AAMI/UL 2800-1-2:2022 - Standard for Interoperable Item Development Life Cycle
• ANSI/AAMI/UL 2800-1-3:2022 - Standard for Interoperable Item Integration Life Cycle
• ANSI/AAMI 2700-1 (2019) Medical Devices And Medical Systems - Essential Safety Requirements For Equipment Comprising The Patient-Centric Integrated Clinical Environment?(formerly?ASTM F2761-09?(2013))
• Series of ISO/IEEE 11073 device communication standards for?Point of Care Devices?and?Personal Health Devices
• National Electrical Manufacturers Association (NEMA) PS 3.1 – 3.20 Digital Imaging and Communications in Medicine (DICOM) Set?for communication and management of medical imaging information and related data.

Here are some additional medical device regulations that should be followed:

• The Standard for Medical Devices – Application of Risk Management to Medical Devices ISO 14971.
• Standard for Medical Electrical Equipment – Part 1: General Requirements for Basic Safety and Essential Performance, IEC 60601-1.
• The Application of Risk Management for IT Networks Incorporating Medical Devices, IEC 80001.

Challenges of Medical Device Interoperability:-

• The safety challenges.?The issue of safety comes first whenever there are data sharing and transfer possibilities so there are some standards for medical devices the Food and Drug Administration (FDA) has approved.
• The outsourcing challenge.?There are a lot of technically specific and costly issues to be addressed to make the best medical alert devices compatible, integrable, connectable, and interoperable with each other. That’s why top medical device companies are looking for?outsourcing opportunities?that match the cost with the quality of medical device product development.
• Control and management challenges.?If some medical devices can interconnect with others, is there a hidden threat here? For example, if we are talking about?implantable medical devices based on the Internet of Things (IoT) technology, can it be controlled from the system it shares data with? Such control is possible, and that poses a threat to patients in the event of unauthorized access to the shared system.
• Disjointed coordination. Improving interoperability requires strong coordination between different organizations, regulators and leaders as well as coordination within organizations. Regulators provide standards and rules for healthcare organizations to follow but organizations that want to be proactive about interoperability should consider creating a dedicated interoperability strategy and make interoperability planning a priority.
• Limited budgets. Not all organizations have the financial or technical resources they need to invest in the technical resources needed to build a truly interoperable system. There may be some government grants available to update health records systems, so organizations should check to see if they’re eligible. Many cloud vendors also offer pay-as-you-go payment models that could make technical expenses more affordable and predictable.
• Diverse technology needs. Organizations need to follow different rules and regulations depending on what type of care they provide and where they're located, so many organizations have highly customized data. Organizations can help connect different internal and external systems through a hybrid cloud platform that gives them options to combine and integrate their data without sacrificing the customizations they need.
• Legacy systems. Healthcare organizations with older legacy systems face the dual challenges of modernizing their systems while also meeting interoperability requirements. Organizations can meet both goals using a hybrid cloud approach to extract data from legacy systems and make it more accessible for modern applications and programs. This approach gives organizations the option to keep data moving while they work on updating their systems.

In conclusion, interoperability offers a significant opportunity to realize the huge potential of connected medical devices. However, there are significant hurdles, both from the market and regulatory perspective.

#medicaldevices #interoperability #healthcare #fda #eu #hospital #regulatorycompliance