Medical device integration with healthcare systems

Medical device integration with healthcare systems

Medical device integration enjoys great recognition – it’s not another trend talked about, but the new normal.

Medical device integration emerged to revolutionize data collection, processing, aggregation, and transmission. Improved accuracy across processes, enhanced workflows, data accessibility, data-backed decision-making – the benefits are undeniable.

In the following overview, we will walk through the basics and answer the most common inquiries being asked.

What software falls under medical devices?

Diagnostic devices

Diagnostic equipment includes devices and procedures being utilized to detect and monitor medical conditions. They analyze physical functions, electrical activity, bones, organs, soft tissues, cellular and molecular structures, and other physiological processes.

For example:

  • MRI machines
  • X-ray systems
  • Ultrasound machines
  • CT scanners

Therapeutic devices

Remedial equipment includes devices and treatments being utilized to detect and manage medical conditions. They deliver physical therapy, mechanical support, fluids, insulin, and more.

For example:

  • Pacemakers
  • Defibrillators
  • Cochlear implants
  • Dialysis machines

Wearable devices

Wearable devices are appliances being utilized while worn on the patient’s body – for example, smart watches. These devices typically analyze heart and respiratory rates, blood pressure, physical activity, sleep patterns, and similar health metrics.

For example:

  • Smart clothing and watches
  • Fitness trackers

as well as those medical devices described below if they are worn.

Monitoring devices

Monitoring devices are gadgets being utilized to continuously or periodically track important health indicators. These devices generally serve clinical purposes and transmit data immediately.  

For example:

  • Heart rate monitors
  • Blood pressure monitors
  • Blood glucose monitors 
  • Wearable health trackers 

What regulations are noteworthy?

HIPAA

HIPAA is a regulation first enacted in 1996 to protect sensitive information from disclosure without consent.

HIPAA establishes national standards to ensure data privacy and security of individual healthcare information. Those concern healthcare organizations, health plans, providers, employers, and other business associates dealing with integrated medical data collection.

GDPR

GDPR is a regulation first passed in 2016 to protect sensitive information of individuals in the European Union.

GDPR settles the collection, processing, storing, and sharing of individual health information across systems. This concerns supervisory authorities, data controllers and processors, joint controllers, third-party providers, and other data subjects.

HL7 

HL7 protocols are standards that establish the framework for appropriate data management across systems. 

HL7 facilitates the integration of devices with centralized healthcare systems – EHR, EMR, HIS, LIS, and others. More specifically, the standards are implemented for seamless data retrieval, data exchange, and transmission, in particular after integrating medical device data into hospital systems.

FHIR

FHIR protocol is another mission-critical standard, specifically designed by the Health Level 7 organization.

FHIR facilitates data transmission between different healthcare platforms, mobile applications, and devices. Essentially speaking, the standard is implemented for uncompromised data consistency and interoperability.

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Medical device integration benefits

Accelerated accuracy

Improved accuracy is important for clinicians to provide high-quality services by using up-to-date information. That enables better assessment, diagnosis, treatment, and overall patient outcomes.

Streamlined workflows

Enhanced workflows are essential for clinicians to provide patient-first care by minimizing manual processes. That means smooth administration, resource allocation, claims processing, and, naturally, patient throughput.

Data accessibility

Medical devices can transmit data directly into centralized healthcare systems to facilitate data accessibility. Chronic conditions, illness exposure, physical disabilities, inconvenient scheduling, and other common barriers are therefore a less complex problem.

Patient records reviewed anywhere and anytime – a true game changer for the medical community.

Data-backed decision-making

Medical devices can provide data required for involved healthcare professionals to make informed decisions. Vital signs, sleep patterns, body weight, physical activity, and other health factors can provide better insight and facilitate further decisions.

Historical records can make the difference.

Medical device integration challenges

Data privacy and security

Data privacy and security are among the most complex challenges that arise when integrating medical devices. Data breaches and exposure, legal liabilities and litigation, cyberattacks, ransomware, downtime, disruption – the threats are significant.

The measures worth implementing might include: 

Data encryptionTo protect health-related information during transmission between systems.– Transport Layer Security 
– Advanced Encryption Standard
– End-to-end encryption
– Key management
Data anonymizationTo protect health-related information by preventing data re-identification.– Data de-identification
– Data masking
– Tokenization
– Pseudonymization
User authentication and authorizationTo restrict unallowed access.– Multi-Factor Authentication 
– Single Sign-On
– OAuth 2.0
– Zero Trust
Regulatory complianceTo demonstrate adequate measures (data encryption, and more) are taken to protect sensitive information.– HIPAA requirements
– GDPR requirements 
– ISO 13485 & 27001
– FDA’s MDDS

Data interoperability

Data interoperability is another tough challenge often arising when selecting and integrating medical devices. Data silos and discrepancy, poor communication and collaboration, incomplete records, patient frustration – the risks are unpleasant, aren’t they?

The measures worth implementing might include:

Common formatsTo ensure the utilized data formats are interpreted across different healthcare systems without trouble.– HL7 standards
– FHIR standards (JSON, XML)
– DICOM
– CDA
Standardized codesTo ensure health-related terminology is interpreted with consistency.– SNOMED 
– LOINC
– ICD-10
– UCUM
API-based exchangeTo facilitate real-time exchange between connected medical devices and other healthcare systems.– HL7 v2/v3 API
– FHIR RESTful API
– FHIR-based SMART
– OAuth 2.0
Regulatory complianceTo demonstrate established standards are followed to protect data collected, processed, stored, and transmitted.– HIPAA requirements
– GDPR requirements 
– ISO 13485 & 27001
– FDA 510(k) & PMA
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How we can help

Abto Software – a custom healthcare software development company with proven, domain-specific expertise. RPA solutions, EHR & EMR systems, telehealth & telemedicine software, medical device integration services – our company can handle any project.

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FAQ

What is medical device integration in a nutshell?

In brief, medical software integration implies the process of connecting medical devices to a healthcare system. It automates data collection, patient management, data aggregation and analysis, medication administration, and other everyday processes.

What is medical device integration software?

In particular, medical device software integration can connect:

  • Diagnostic devices
  • Therapeutic devices
  • Wearable devices
  • Monitoring devices
  • Imaging devices
  • Surgical devices
  • Life support devices
  • Medication administration devices
  • Rehabilitation devices
  • Laboratory devices
What are the benefits of medical device integration?

As you might know, medical software integration has great benefits for both patients and healthcare providers. Improved accuracy, enhanced workflows, data accessibility and management, data-backed decision-making – the perks are evident.

How is medical device integration performed?

In general, medical device integration includes these steps:

  • Business analysis and assessment
  • Requirement gathering
  • Compatibility evaluation
  • Architecture design
  • Data standardization
  • Data mapping
  • Connectivity establishment
  • Thorough testing
  • Product implementation
  • Ongoing monitoring, technical support, and maintenance

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