AI & Data
November 17, 2025

Chinmay Chandgude
How IoT Is Transforming Healthcare Through Remote Patient Monitoring


The pandemic redefined how care is delivered by pushing hospitals, startups, and MedTech innovators to rethink the boundaries of remote patient monitoring. Today, IoT in healthcare is the backbone of remote patient monitoring and connected medical devices that allow clinicians to track patient vitals in real time. According to McKinsey (2025), more than 60 % of new medical devices now ship with embedded connectivity features, underscoring the sector’s pivot toward data-driven, interoperable systems built for continuous patient engagement.
For healthcare organizations, this shift not only offers new possibilities such as earlier detection, better adherence, and reduced readmissions but also new liabilities. Each connected sensor introduces potential exposure points under HIPAA § 164.312 and the FDA’s Cybersecurity Guidance (2023). As the number of home-based devices grows, so does the urgency to build systems that are secure, compliant, and clinically validated from the start FDA Cybersecurity 2023.
What is IoT in healthcare?
IoT in healthcare refers to a connected network of smart medical devices, wearables, and sensors that collect and transmit patient data in real time. These devices, ranging from continuous glucose monitors to ECG patches and connected inhalers, enable clinicians to monitor vital signs remotely and make proactive interventions. Each data point captured is encrypted, transmitted through secure channels, and stored in compliance with HIPAA, GDPR, and ISO 27001 standards to protect patient privacy.
How do at-home health monitoring devices work?
The growing adoption of IoT in healthcare marks a decisive shift toward patient-centric and preventive care. Aging populations, chronic illnesses, and hospital capacity limits are pushing health systems to monitor patients at home, not just in clinics. According to a Journal of mHealth report, remote patient monitoring (RPM) has reduced hospital readmissions by 38 % and improved medication adherence by over 25 % in 2024.
At-home IoT devices extend the reach of clinical supervision while maintaining compliance with HIPAA and FDA SaMD guidelines. These devices transmit continuous streams of physiological data to healthcare IoT platforms, enabling clinicians to intervene earlier and personalize treatment. The result is a scalable model of care that improves outcomes and reduces administrative burden.
However, success in this space depends on more than connectivity. To operate safely and effectively, connected medical devices must integrate with existing EHR and telehealth systems through FHIR-based APIs and validated data pipelines. Without this interoperability, device data risks becoming unstructured noise.
What does a healthcare-grade IoT architecture look like?
Building a connected health ecosystem requires an engineered system designed for traceability, validation, and compliance at every layer. A well-architected IoT in healthcare system integrates hardware, connectivity, data management, applications, and regulatory safeguards to ensure uninterrupted, audit-ready operations.
A typical healthcare IoT stack includes:
Device Layer – Comprising FDA-classified sensors and embedded firmware validated under IEC 62304 and ISO 14971 to manage risk from the earliest design phase.
Connectivity Layer – Secure transmission channels using Bluetooth Low Energy (BLE), Wi-Fi 6, or 5G with authentication and encrypted pairing protocols to prevent unauthorized access.
Data Layer – Cloud ingestion pipelines that structure and transmit medical data via HL7 FHIR APIs, enabling interoperability in healthcare systems.
Application Layer – Web and mobile interfaces for clinicians and patients, incorporating user authentication, audit logging, and clinical alert systems validated against IEC 62366-1 usability standards.
Compliance Layer – Ensuring adherence to HIPAA, GDPR, SOC 2 Type II, and ISO 27001, supported by continuous audit trails and role-based access controls.
When implemented correctly, IoT in healthcare systems bridges the gap between patients and providers by transforming data silos into unified, interoperable workflows. This interoperability is central to building intelligent healthcare systems capable of AI-driven decision support and real-time clinical documentation, a topic explored further in Latent’s article on NLP in Healthcare.
How is patient data kept secure in IoT healthcare systems?
As connectivity grows, so does exposure. The same data streams that make IoT in healthcare revolutionary also make it vulnerable. Unsecured APIs, outdated firmware, and unencrypted transmissions are among the most common causes of data breaches in connected health systems. According to the HIPAA Journal (2025), over 80% of healthcare organizations reported at least one IoT-related security incident in the past year.
To mitigate this, modern healthcare IoT platforms must adopt a validation-driven cybersecurity framework anchored in industry standards such as NIST 800-30, FDA Cybersecurity Guidance (2023), and HIPAA §164.312(b) audit control requirements. This approach ensures that every data exchange is authenticated, encrypted, and logged.
A secure IoT system in healthcare typically includes:
Role-Based Access Control (RBAC) to ensure users only access authorized data.
Multi-Factor Authentication (MFA) for clinician and admin accounts.
End-to-End Encryption (TLS 1.2+, AES-256) for data in motion and at rest.
Automatic Firmware Updates with signature validation.
Vulnerability Disclosure Programs and patch management policies as part of post-market cybersecurity.
How do you make device data interoperable?
Even the most advanced IoT in healthcare system loses value if its data remains siloed. Without interoperability, continuous health data from connected devices can’t inform clinical workflows, predictive analytics, or population health programs. The ONC’s 2024 Interoperability Standards note that less than 45% of IoT-enabled medical devices seamlessly integrate with EHR systems.
Interoperability ensures that every data packet, from a patient’s home pulse oximeter to a hospital’s cloud dashboard, follows structured formats like HL7 FHIR, IEEE 11073, and DICOM. These standards define how device data becomes machine-readable and clinically actionable. (Source)
Under the ONC Cures Act, providers must ensure that connected systems support patient access and data sharing without creating “information blocking.” Each integration Latent builds undergoes FHIR endpoint validation and EHR conformance testing before deployment, ensuring data integrity, traceability, and audit readiness. For deeper insight into how data unification supports real-time care delivery, refer to Latent’s Insight on Benefits of Pharmacy Management Systems, where interoperability was central to reducing dispensing errors and improving compliance reporting.
How is AI using IoT health data?
Once an IoT in healthcare ecosystem achieves interoperability, it unlocks the foundation for AI-driven decision support. The combination of connected sensors, structured data, and validated models enables predictive alerts, early diagnostics, and automation across clinical workflows. This shift marks the evolution from data collection to data intelligence.
For example, continuous ECG data from FDA-cleared wearables can feed machine learning models trained under Good Machine Learning Practices (GMLP), identifying early arrhythmia risks 48–72 hours before clinical onset. Similarly, AI models analyzing oxygen saturation and heart rate variability can detect respiratory distress in COPD patients, prompting telehealth teams to intervene before hospitalization.
Under FDA’s Software as a Medical Device (SaMD) framework, AI systems that drive or influence clinical decisions are regulated as medical devices themselves. Each algorithm must undergo validation, version control, and post-market performance monitoring. This ensures every model prediction is traceable, explainable, and clinically verified before it informs care.
This approach mirrors the one where structured, machine-readable data forms the backbone of clinical AI documentation. When IoT data follows the same validated structure, healthcare organizations can layer AI safely without compromising compliance or trust.
Compliance & Regulatory Checklist for IoT in Healthcare
A connected-care system is only as strong as its documentation. Below is a quick-reference compliance map Latent uses when engineering IoT in healthcare solutions. Each control is tied to a standard, the validation activity, and the required artifact making it easier for engineering and quality teams to stay audit-ready.
Category | Standard / Regulation | Validation Action | Deliverable / Artifact |
Software Lifecycle | IEC 62304 | Develop, verify & validate firmware + cloud components | Software V&V Report, Traceability Matrix |
Risk Management | ISO 14971 | Conduct hazard analysis + risk control verification | Risk Management File (RMF) |
Usability Engineering | IEC 62366-1 | Perform usability tests under real-world conditions | Human Factors Validation Report |
Cybersecurity | FDA Cybersecurity Guidance (2023), NIST 800-30 | Threat modeling, penetration testing, SBOM validation | Cybersecurity Risk Assessment, SBOM |
Data Privacy & Security | HIPAA §164.312, ISO 27001 | Encrypt data at rest & in transit; enable audit logs | Security Audit Log, Encryption Checklist |
Interoperability | HL7 FHIR, IEEE 11073, ONC Cures Act | FHIR endpoint validation, EHR integration testing | Interoperability Validation Report |
Quality System | FDA 21 CFR Part 820 (QSR) | Maintain Design History File & Device Master Record | DHF, DMR, CAPA Logs |
Post-Market Surveillance | FDA MDR 803, ISO 13485 §8 | Monitor field performance + security events | PMS Report, Vulnerability Disclosure Logs |
What’s the future of IoT in healthcare?
Every connected system must prove three things: that data is secure, that workflows are interoperable, and that each decision made from sensor data can stand up to clinical and regulatory scrutiny. This is why validation, traceability, and post-market surveillance form the backbone of Latent’s engineering methodology. In a healthcare ecosystem increasingly dependent on AI and automation, compliance is a design principle.
The next generation of healthcare innovation will come from teams that understand this intersection: technology that moves fast, but within the rails of FDA, HIPAA, and ISO 13485 frameworks. Teams that design with interoperability, build with validation, and launch with audit readiness will lead the connected-care revolution.
At Latent, we help organizations build secure, interoperable, and AI-ready systems from day one. Whether you’re developing a remote-monitoring platform, integrating IoT data into your EHR modernization stack, or building FDA-classified connected devices, our approach ensures compliance and clinical confidence scale together.
The pandemic redefined how care is delivered by pushing hospitals, startups, and MedTech innovators to rethink the boundaries of remote patient monitoring. Today, IoT in healthcare is the backbone of remote patient monitoring and connected medical devices that allow clinicians to track patient vitals in real time. According to McKinsey (2025), more than 60 % of new medical devices now ship with embedded connectivity features, underscoring the sector’s pivot toward data-driven, interoperable systems built for continuous patient engagement.
For healthcare organizations, this shift not only offers new possibilities such as earlier detection, better adherence, and reduced readmissions but also new liabilities. Each connected sensor introduces potential exposure points under HIPAA § 164.312 and the FDA’s Cybersecurity Guidance (2023). As the number of home-based devices grows, so does the urgency to build systems that are secure, compliant, and clinically validated from the start FDA Cybersecurity 2023.
What is IoT in healthcare?
IoT in healthcare refers to a connected network of smart medical devices, wearables, and sensors that collect and transmit patient data in real time. These devices, ranging from continuous glucose monitors to ECG patches and connected inhalers, enable clinicians to monitor vital signs remotely and make proactive interventions. Each data point captured is encrypted, transmitted through secure channels, and stored in compliance with HIPAA, GDPR, and ISO 27001 standards to protect patient privacy.
How do at-home health monitoring devices work?
The growing adoption of IoT in healthcare marks a decisive shift toward patient-centric and preventive care. Aging populations, chronic illnesses, and hospital capacity limits are pushing health systems to monitor patients at home, not just in clinics. According to a Journal of mHealth report, remote patient monitoring (RPM) has reduced hospital readmissions by 38 % and improved medication adherence by over 25 % in 2024.
At-home IoT devices extend the reach of clinical supervision while maintaining compliance with HIPAA and FDA SaMD guidelines. These devices transmit continuous streams of physiological data to healthcare IoT platforms, enabling clinicians to intervene earlier and personalize treatment. The result is a scalable model of care that improves outcomes and reduces administrative burden.
However, success in this space depends on more than connectivity. To operate safely and effectively, connected medical devices must integrate with existing EHR and telehealth systems through FHIR-based APIs and validated data pipelines. Without this interoperability, device data risks becoming unstructured noise.
What does a healthcare-grade IoT architecture look like?
Building a connected health ecosystem requires an engineered system designed for traceability, validation, and compliance at every layer. A well-architected IoT in healthcare system integrates hardware, connectivity, data management, applications, and regulatory safeguards to ensure uninterrupted, audit-ready operations.
A typical healthcare IoT stack includes:
Device Layer – Comprising FDA-classified sensors and embedded firmware validated under IEC 62304 and ISO 14971 to manage risk from the earliest design phase.
Connectivity Layer – Secure transmission channels using Bluetooth Low Energy (BLE), Wi-Fi 6, or 5G with authentication and encrypted pairing protocols to prevent unauthorized access.
Data Layer – Cloud ingestion pipelines that structure and transmit medical data via HL7 FHIR APIs, enabling interoperability in healthcare systems.
Application Layer – Web and mobile interfaces for clinicians and patients, incorporating user authentication, audit logging, and clinical alert systems validated against IEC 62366-1 usability standards.
Compliance Layer – Ensuring adherence to HIPAA, GDPR, SOC 2 Type II, and ISO 27001, supported by continuous audit trails and role-based access controls.
When implemented correctly, IoT in healthcare systems bridges the gap between patients and providers by transforming data silos into unified, interoperable workflows. This interoperability is central to building intelligent healthcare systems capable of AI-driven decision support and real-time clinical documentation, a topic explored further in Latent’s article on NLP in Healthcare.
How is patient data kept secure in IoT healthcare systems?
As connectivity grows, so does exposure. The same data streams that make IoT in healthcare revolutionary also make it vulnerable. Unsecured APIs, outdated firmware, and unencrypted transmissions are among the most common causes of data breaches in connected health systems. According to the HIPAA Journal (2025), over 80% of healthcare organizations reported at least one IoT-related security incident in the past year.
To mitigate this, modern healthcare IoT platforms must adopt a validation-driven cybersecurity framework anchored in industry standards such as NIST 800-30, FDA Cybersecurity Guidance (2023), and HIPAA §164.312(b) audit control requirements. This approach ensures that every data exchange is authenticated, encrypted, and logged.
A secure IoT system in healthcare typically includes:
Role-Based Access Control (RBAC) to ensure users only access authorized data.
Multi-Factor Authentication (MFA) for clinician and admin accounts.
End-to-End Encryption (TLS 1.2+, AES-256) for data in motion and at rest.
Automatic Firmware Updates with signature validation.
Vulnerability Disclosure Programs and patch management policies as part of post-market cybersecurity.
How do you make device data interoperable?
Even the most advanced IoT in healthcare system loses value if its data remains siloed. Without interoperability, continuous health data from connected devices can’t inform clinical workflows, predictive analytics, or population health programs. The ONC’s 2024 Interoperability Standards note that less than 45% of IoT-enabled medical devices seamlessly integrate with EHR systems.
Interoperability ensures that every data packet, from a patient’s home pulse oximeter to a hospital’s cloud dashboard, follows structured formats like HL7 FHIR, IEEE 11073, and DICOM. These standards define how device data becomes machine-readable and clinically actionable. (Source)
Under the ONC Cures Act, providers must ensure that connected systems support patient access and data sharing without creating “information blocking.” Each integration Latent builds undergoes FHIR endpoint validation and EHR conformance testing before deployment, ensuring data integrity, traceability, and audit readiness. For deeper insight into how data unification supports real-time care delivery, refer to Latent’s Insight on Benefits of Pharmacy Management Systems, where interoperability was central to reducing dispensing errors and improving compliance reporting.
How is AI using IoT health data?
Once an IoT in healthcare ecosystem achieves interoperability, it unlocks the foundation for AI-driven decision support. The combination of connected sensors, structured data, and validated models enables predictive alerts, early diagnostics, and automation across clinical workflows. This shift marks the evolution from data collection to data intelligence.
For example, continuous ECG data from FDA-cleared wearables can feed machine learning models trained under Good Machine Learning Practices (GMLP), identifying early arrhythmia risks 48–72 hours before clinical onset. Similarly, AI models analyzing oxygen saturation and heart rate variability can detect respiratory distress in COPD patients, prompting telehealth teams to intervene before hospitalization.
Under FDA’s Software as a Medical Device (SaMD) framework, AI systems that drive or influence clinical decisions are regulated as medical devices themselves. Each algorithm must undergo validation, version control, and post-market performance monitoring. This ensures every model prediction is traceable, explainable, and clinically verified before it informs care.
This approach mirrors the one where structured, machine-readable data forms the backbone of clinical AI documentation. When IoT data follows the same validated structure, healthcare organizations can layer AI safely without compromising compliance or trust.
Compliance & Regulatory Checklist for IoT in Healthcare
A connected-care system is only as strong as its documentation. Below is a quick-reference compliance map Latent uses when engineering IoT in healthcare solutions. Each control is tied to a standard, the validation activity, and the required artifact making it easier for engineering and quality teams to stay audit-ready.
Category | Standard / Regulation | Validation Action | Deliverable / Artifact |
Software Lifecycle | IEC 62304 | Develop, verify & validate firmware + cloud components | Software V&V Report, Traceability Matrix |
Risk Management | ISO 14971 | Conduct hazard analysis + risk control verification | Risk Management File (RMF) |
Usability Engineering | IEC 62366-1 | Perform usability tests under real-world conditions | Human Factors Validation Report |
Cybersecurity | FDA Cybersecurity Guidance (2023), NIST 800-30 | Threat modeling, penetration testing, SBOM validation | Cybersecurity Risk Assessment, SBOM |
Data Privacy & Security | HIPAA §164.312, ISO 27001 | Encrypt data at rest & in transit; enable audit logs | Security Audit Log, Encryption Checklist |
Interoperability | HL7 FHIR, IEEE 11073, ONC Cures Act | FHIR endpoint validation, EHR integration testing | Interoperability Validation Report |
Quality System | FDA 21 CFR Part 820 (QSR) | Maintain Design History File & Device Master Record | DHF, DMR, CAPA Logs |
Post-Market Surveillance | FDA MDR 803, ISO 13485 §8 | Monitor field performance + security events | PMS Report, Vulnerability Disclosure Logs |
What’s the future of IoT in healthcare?
Every connected system must prove three things: that data is secure, that workflows are interoperable, and that each decision made from sensor data can stand up to clinical and regulatory scrutiny. This is why validation, traceability, and post-market surveillance form the backbone of Latent’s engineering methodology. In a healthcare ecosystem increasingly dependent on AI and automation, compliance is a design principle.
The next generation of healthcare innovation will come from teams that understand this intersection: technology that moves fast, but within the rails of FDA, HIPAA, and ISO 13485 frameworks. Teams that design with interoperability, build with validation, and launch with audit readiness will lead the connected-care revolution.
At Latent, we help organizations build secure, interoperable, and AI-ready systems from day one. Whether you’re developing a remote-monitoring platform, integrating IoT data into your EHR modernization stack, or building FDA-classified connected devices, our approach ensures compliance and clinical confidence scale together.

Chinmay Chandgude is a partner at Latent with over 9 years of experience in building custom digital platforms for healthcare and finance sectors. He focuses on creating scalable and secure web and mobile applications to drive technological transformation. Based in Pune, India, Chinmay is passionate about delivering user-centric solutions that improve efficiency and reduce costs.



