This document provides an overview and introduction to ISO/IEC 80001-1, which establishes a risk management framework for IT networks incorporating medical devices. It describes why the standard was created, as networks are becoming more complex and integrated. ISO/IEC 80001-1 aims to ensure the safety, effectiveness, and security of medical IT networks by defining roles and responsibilities for manufacturers, healthcare organizations, and regulators during the risk management process. It also introduces the new role of a "Medical IT-Network Risk Manager" within healthcare organizations to help manage risks and communication relating to networked medical devices.
The document discusses HP's Digital Hospital solution framework which was implemented at St. Olav's Hospital in Norway. The framework utilizes a converged IP network to integrate clinical systems, devices, and applications. This allows for improved communication and information sharing. At St. Olav's, benefits included increased productivity, shorter patient stays, and better patient care through improved access to data. The Digital Hospital framework can help healthcare providers optimize resources and improve quality of care through IT and application integration.
This document provides an introduction to medical device security. It defines medical devices and provides examples. Intended use determines if a device is regulated. Software can be a medical device. Regulations and standards like IEC 62443 govern security. Old devices increase interconnectivity and associated risks. Security goals are confidentiality, integrity and availability to prevent patient harm. Common vulnerabilities include unpatched systems and weak credentials. Risk assessments must consider safety impacts. Manufacturers must integrate security into development and handle incidents and vulnerabilities.
Network Connected Medical Devices - A Case StudySophiaPalmira
In this session, we welcome Shankar Somasundaram, CEO of Asimily, Priyanka Upendra, Quality Compliance Director at Banner Health, and Carrie Whysall. Director of Managed Security Services at CynergisTek.
Together, they will discuss medical device security, covering all you need to know from medical device assessments to remediation efforts. Attendees will leave this session knowing how to apply what they have learned about medical device security in real life.
Wireless network design hospital case studynikshaikh786
The document provides instructions and considerations for designing a unified wireless network (UWN) for a hospital. It summarizes the results of an RF site survey that was conducted, which identified locations for placing access points but found no sources of interference. It lists the steps required to design the UWN, which include determining controller placement and models, separating wireless traffic for different staff groups according to HIPAA, defining the IP addressing scheme for wireless networks, configuring mobility groups, handling wireless access for remote clinics, and supporting secure guest wireless access.
Bon Secours health: system network design and delivery case studyeircom
Bon Secours Health System upgraded their network across multiple hospital sites to support growing IT needs and a new diagnostic imaging system. They partnered with eircom to implement a high-bandwidth Next Generation Network providing up to 50Mbps connectivity. This allows clinicians to securely access and share patient images digitally across locations. The new network provides improved clinical workflows and reduced patient wait times. Ian Brennan of Bon Secours says the network's reliability, performance, security and scalability are critical thanks to their complex clinical systems and geographic spread across Ireland.
The transformation to digital imaging is complete. The transformation to digital records is underway. The addition of networking capability to clinical devices (pumps, patient monitors, nurse call systems) and everyday objects (doors, thermometers, water sensors, signs) grows with each passing month. Your network needs to be ready for the hyper-connected near term.
http://enterprise.alcatel-lucent.com/healthcare
IEC 80001 and Planning for Wi-Fi Capable Medical DevicesAli Youssef
This document summarizes a presentation about planning for Wi-Fi capable medical devices given by Ali Youssef, a senior clinical mobile solutions architect at Henry Ford Health System. It discusses Henry Ford's large Wi-Fi network supporting over 14,000 daily connections across its facilities. It describes some challenges faced with integrating different types of Wi-Fi medical devices and how they were addressed. It also discusses trends in mobility, the IEC 80001 standard for managing risks with medical devices on networks, and Henry Ford's process for certifying and onboarding new Wi-Fi medical devices onto its network.
This document provides an overview and introduction to ISO/IEC 80001-1, which establishes a risk management framework for IT networks incorporating medical devices. It describes why the standard was created, as networks are becoming more complex and integrated. ISO/IEC 80001-1 aims to ensure the safety, effectiveness, and security of medical IT networks by defining roles and responsibilities for manufacturers, healthcare organizations, and regulators during the risk management process. It also introduces the new role of a "Medical IT-Network Risk Manager" within healthcare organizations to help manage risks and communication relating to networked medical devices.
The document discusses HP's Digital Hospital solution framework which was implemented at St. Olav's Hospital in Norway. The framework utilizes a converged IP network to integrate clinical systems, devices, and applications. This allows for improved communication and information sharing. At St. Olav's, benefits included increased productivity, shorter patient stays, and better patient care through improved access to data. The Digital Hospital framework can help healthcare providers optimize resources and improve quality of care through IT and application integration.
This document provides an introduction to medical device security. It defines medical devices and provides examples. Intended use determines if a device is regulated. Software can be a medical device. Regulations and standards like IEC 62443 govern security. Old devices increase interconnectivity and associated risks. Security goals are confidentiality, integrity and availability to prevent patient harm. Common vulnerabilities include unpatched systems and weak credentials. Risk assessments must consider safety impacts. Manufacturers must integrate security into development and handle incidents and vulnerabilities.
Network Connected Medical Devices - A Case StudySophiaPalmira
In this session, we welcome Shankar Somasundaram, CEO of Asimily, Priyanka Upendra, Quality Compliance Director at Banner Health, and Carrie Whysall. Director of Managed Security Services at CynergisTek.
Together, they will discuss medical device security, covering all you need to know from medical device assessments to remediation efforts. Attendees will leave this session knowing how to apply what they have learned about medical device security in real life.
Wireless network design hospital case studynikshaikh786
The document provides instructions and considerations for designing a unified wireless network (UWN) for a hospital. It summarizes the results of an RF site survey that was conducted, which identified locations for placing access points but found no sources of interference. It lists the steps required to design the UWN, which include determining controller placement and models, separating wireless traffic for different staff groups according to HIPAA, defining the IP addressing scheme for wireless networks, configuring mobility groups, handling wireless access for remote clinics, and supporting secure guest wireless access.
Bon Secours health: system network design and delivery case studyeircom
Bon Secours Health System upgraded their network across multiple hospital sites to support growing IT needs and a new diagnostic imaging system. They partnered with eircom to implement a high-bandwidth Next Generation Network providing up to 50Mbps connectivity. This allows clinicians to securely access and share patient images digitally across locations. The new network provides improved clinical workflows and reduced patient wait times. Ian Brennan of Bon Secours says the network's reliability, performance, security and scalability are critical thanks to their complex clinical systems and geographic spread across Ireland.
The transformation to digital imaging is complete. The transformation to digital records is underway. The addition of networking capability to clinical devices (pumps, patient monitors, nurse call systems) and everyday objects (doors, thermometers, water sensors, signs) grows with each passing month. Your network needs to be ready for the hyper-connected near term.
http://enterprise.alcatel-lucent.com/healthcare
IEC 80001 and Planning for Wi-Fi Capable Medical DevicesAli Youssef
This document summarizes a presentation about planning for Wi-Fi capable medical devices given by Ali Youssef, a senior clinical mobile solutions architect at Henry Ford Health System. It discusses Henry Ford's large Wi-Fi network supporting over 14,000 daily connections across its facilities. It describes some challenges faced with integrating different types of Wi-Fi medical devices and how they were addressed. It also discusses trends in mobility, the IEC 80001 standard for managing risks with medical devices on networks, and Henry Ford's process for certifying and onboarding new Wi-Fi medical devices onto its network.
Avaali works with global medical device manufacturers, managed care providers, and accountable care organizations to enable wireless monitoring. These applications will not only improve the access to care while increasing the quality of care but also reduce the cost of care.
This document describes a dynamic medical machine that is deployed in rural areas without easy access to doctors. The machine contains sensors like a temperature sensor, heart rate sensor, and ultrasonic sensor to monitor patients' vital signs. It is connected to a doctor via video and audio calls to allow virtual consultations. Based on the doctor's diagnosis and prescription, the machine automatically dispenses the appropriate medicines to the patient. This aims to make healthcare more accessible for common illnesses in remote locations while reducing costs.
According to a report from MarketResearch.com, millions of new Internet of Medical Things (IoMT) will be added to health systems and the market segment is poised to hit $117 billion by 2020. Medical device manufacturers have traditionally focused on patient safety and time to market rather than security. Long FDA approval cycles mean that approved devices are often running outdated operating systems versions with known vulnerabilities and limited or no patching ability. This lack of adequate security in IoT and IoMT is why Gartner is predicting that by 2020 25% of all enterprise breaches will involve IoT. Securing IoMT requires close collaboration between biomedical and IT teams and a plan to address three core areas of IoMT security – physical, connection and data. This session will focus on practical steps to improving IoMT security without expensive infrastructure upgrades or wholesale legacy medical device replacements.
This document provides an executive summary and network design plans for a new medical facility network. It includes an overview of the physical and logical network diagrams. It also outlines various network policies for internet access, printing, storage, email usage, user administration, naming conventions, protocols, workstation configuration, network device placement, and security. The security policies address procedures for user accounts, passwords, network access, firewalls, encryption, logging, physical access, intrusion detection/prevention, and vulnerability assessments. Violations of the security policy are also addressed. The network is designed to support 225 users while meeting HIPAA requirements and allowing offsite access.
Iot, cloud and healthcare - Challenges and OpportunitiesArash Ghadar
The document discusses the opportunities and challenges of using IoT, cloud computing, and telehealth in healthcare. It provides several case studies of current IoT applications in industries like oil & gas, food, and medical. Key challenges identified are ensuring timely and reliable data delivery, network and data security, and complex certification processes. The future of telehealth is seen as improving healthcare access and reducing costs through remote monitoring and treatment of chronic diseases, though security and regulatory barriers must still be addressed.
Security Requirements, Counterattacks and Projects in Healthcare Applications...arpublication
Healthcare applications are well thought-out as interesting fields for WSN where patients can be examine using wireless medical sensor networks. Inside the hospital or extensive care surroundings there is a tempting need for steady monitoring of essential body functions and support for patient mobility. Recent research cantered on patient reliable communication, mobility, and energy-efficient routing. Yet deploying new expertise in healthcare applications presents some understandable security concerns which are the important concern in the inclusive deployment of wireless patient monitoring systems. This manuscript presents a survey of the security features, its counter attacks in healthcare applications including some proposed projects which have been done recently.
RTI Connext DDS messaging software helps evolve standalone systems to integrated distributed systems, connect devices to improve patient outcomes, and replace dedicated point-to-point wiring with networks.
A wide range of additional benefits are possible, including improved diagnosis and safety, delegated care or treatment, and smarter machine assistance for healthcare.
Information technology in health care managementmohamedmoosa2
The document discusses various roles of information technology in healthcare management. It describes how IT helps with communication between devices, teams, patients and providers. It enables secure exchange of health information and establishes reputations as stewards of private data. The roles of IT include supporting accurate operations, quality care through reliable technology, and cost reductions through automation. IT specialists discussed include systems analysts, database managers, networking specialists and software programmers. Future IT jobs may involve areas like 3D printing, artificial intelligence and robotics. The document also lists major US and Indian healthcare information system companies.
The document discusses the benefits of mobile device connectivity for healthcare. It notes that over 30% of physicians make decisions with incomplete information, and mobile technologies could eliminate 11-30% of office visits. Remote monitoring is shown to reduce costs and hospital admissions for conditions like diabetes, congestive heart failure, and COPD. Widespread use of remote monitoring for chronic conditions could save over $200 billion in healthcare costs over 25 years. Standards-based WiFi technologies can effectively support remote patient monitoring.
Healthcare IoT and Analytics to treat Parkinsonsrcnossen
Rick Cnossen from Intel discussed transforming healthcare with the Internet of Things (IoT). IoT can help drive outcomes-based payment, wellness programs, reduce costs of chronic care, and help with clinical trials. Intel's vision is to connect computing technology to people worldwide. Wearable devices can help manage Parkinson's disease by continuously tracking symptoms, activity, sleep, and tremors to provide accurate reports between doctor visits. Big data analytics of information from many patients can provide insights to help research and pharmaceuticals. Challenges to address include the lack of objective measures between infrequent doctor visits and the high costs and small sizes of clinical trials.
IRJET- Android base Healthcare Monitoring and Management System using IoTIRJET Journal
This document proposes an Android-based healthcare monitoring and management system using the Internet of Things (IoT). The system uses a body sensor network (BSN) where sensors attached to a patient's body can monitor vital signs wirelessly. The sensor data is sent to a healthcare center via the BSN. The healthcare center then analyzes the data and provides real-time feedback and alerts to patients and their families. This ensures remote patient monitoring and management while improving comfort and healthcare quality. The document discusses the system functionality, literature review on similar systems, algorithms used and security analysis to show how the proposed system addresses security needs in BSN-based healthcare more effectively than previous systems.
The document discusses research on using wireless sensor networks for healthcare monitoring. It proposes using environmental and physiological sensor nodes integrated into wireless networks to remotely monitor human health conditions and environment. This could help build an e-healthcare system that monitors, predicts, and informs medical staff to prevent diseases while not interrupting daily activities. The system aims to link human health with environmental monitoring for a holistic view of well-being. Future work includes further development of tools, system design and implementation, analysis of results, and publishing papers on this research topic.
Killed by code - mobile medical devicesFlaskdata.io
There is a perfect storm of consumer electronics, mobile communications and customer need - the need to help people manage chronic disease like Parkinson, diabetes and MSA and sustain life with pacemakers and ICDs
How Interconnectivity Is Enabling The Future Of Patient-Driven HealthKent State University
1) Connected health technologies like wearables, home devices, and remote patient monitoring apps have the potential to transform chronic disease management by allowing patients to manage conditions at home independently.
2) Remote patient monitoring is increasingly being used to monitor chronic conditions like congestive heart failure and is showing success in reducing hospital admissions. Technologies also support healthy aging by enabling aging in place.
3) While connectivity offers opportunities, deploying and managing these systems poses challenges for providers and patients regarding technical support, data security and privacy, and maintaining remote monitoring equipment.
- Bethesda Medical Center will be a private specialty teaching hospital in Port-au-Prince, Haiti providing emergency, inpatient, and outpatient consultative services. It will have a North American-Haiti partnership structure and teaching faculty.
- The technology architecture principles focus on reducing complexity, using low-cost and open solutions, leveraging cellular infrastructure and smartphones, and standardizing data formats.
- The document outlines the technology architectures for local sites, regional centers, the hospital, and a future provider tele-health monitoring system. It emphasizes using minimal local infrastructure and cellular or cloud-based solutions where possible.
Fundamentals of Medical Device ConnectivityNuvon, Inc.
I this three part series, John R. Zaleski, PhD, CPHIMS, Vice President of Clinical Applications & CTO of Nuvon, Inc. discusses 3 areas of Medical Device Connectivity beginning with the Fundamentals, to Clinical Decision Support, and next generation Mobile Device Connectivity.
The document discusses how the Data Distribution Service (DDS) middleware standard can enable integration of medical devices and systems. DDS allows devices and applications to share information through a global data space and supports real-time performance, reliability, and interoperability across platforms. Examples shown include using DDS for integrated control of medical imaging devices like CT and MRI scanners, particle therapy systems, surgical robotics, and connecting monitoring devices at the hospital, ambulance, and clinical levels. DDS provides a common information model and quality of service policies to ensure safe and effective data sharing across disconnected medical systems.
The objective of project is to improve end-users’ Healthcare experience through its IoT-based Healthcare services and to support business incubation scheme with better
regulatory support
Patient Health Monitoring System using IOTIRJET Journal
This document describes a patient health monitoring system using the Internet of Things. The system uses sensors to measure a patient's temperature, heart rate, and other vital signs. The sensor data is sent via Bluetooth or WiFi to an Android smartphone app. The app monitors for any abnormalities and will send alerts to the patient's doctor and relatives if issues are detected. The system aims to allow for continuous at-home monitoring of patients after they leave the hospital to help prevent health issues and speed up response times in emergencies.
Binseng Wang, ScD, CCE – Vice President, Performance Management & Regulatory Compliance, ARAMARK Healthcare’s Clinical Technology Services
Clinical engineering (CE) professionals have realized for some time that the “preventive maintenance” (PM) that they have been performing for many years is no longer able to prevent any failures, although some safety and performance inspections (SPIs) can help detect hidden and potential failures that affect patient safety. To help CE professionals decide whether they should continue to perform scheduled maintenance (SM) or not, a systematic method for determining maintenance effectiveness has been developed. This method uses a small set of codes to classify failures found during repairs and SM (PMs and SPIs). Analysis of the failure patterns and their effects on patients and users allows CE professionals to compare the effectiveness of different maintenance strategies, and justify changes in strategies, such as decreasing SM, deploying statistical sampling, or even eliminating SM.
As the impact of healthcare reform on the U.S. delivery system comes into focus, there is little doubt that it is a “game changer” for clinical engineering and biomedical equipment technology. Carol will describe and discuss the future of the CE and BMET professions under new regulations and a new payment system. She will address why medical devices will cost much more, why equipment must have longer life cycles, why CEs and BMETs will and must have more involvement in IT-related activities, how CEs’ and BMETs’ responsibilities in regulatory compliance will expand and how you can prepare for this new environment.
About Carol Davis-Smith, CCE
Career Summary
Carol Davis-Smith is a Director in Premier’s Consulting Solution Division with responsibility for the development and deployment of capital lifecycle management processes and tools to Premier staff and owners.
Education and Affiliations
Ms. Davis-Smith received a B.S. in bioengineering technology
from the University of Dayton and an M.S. in engineering from the University of Arizona. She is a certified clinical engineer and a member of the Association for the Advancement of Medical Instrumentation (AAMI). Over the past 20 years, she has presented and published papers on a variety of clinical engineering and capital contracting topics. In 2009, Ms. Davis-Smith received the AAMI Clinical Engineering Achievement Award.
Avaali works with global medical device manufacturers, managed care providers, and accountable care organizations to enable wireless monitoring. These applications will not only improve the access to care while increasing the quality of care but also reduce the cost of care.
This document describes a dynamic medical machine that is deployed in rural areas without easy access to doctors. The machine contains sensors like a temperature sensor, heart rate sensor, and ultrasonic sensor to monitor patients' vital signs. It is connected to a doctor via video and audio calls to allow virtual consultations. Based on the doctor's diagnosis and prescription, the machine automatically dispenses the appropriate medicines to the patient. This aims to make healthcare more accessible for common illnesses in remote locations while reducing costs.
According to a report from MarketResearch.com, millions of new Internet of Medical Things (IoMT) will be added to health systems and the market segment is poised to hit $117 billion by 2020. Medical device manufacturers have traditionally focused on patient safety and time to market rather than security. Long FDA approval cycles mean that approved devices are often running outdated operating systems versions with known vulnerabilities and limited or no patching ability. This lack of adequate security in IoT and IoMT is why Gartner is predicting that by 2020 25% of all enterprise breaches will involve IoT. Securing IoMT requires close collaboration between biomedical and IT teams and a plan to address three core areas of IoMT security – physical, connection and data. This session will focus on practical steps to improving IoMT security without expensive infrastructure upgrades or wholesale legacy medical device replacements.
This document provides an executive summary and network design plans for a new medical facility network. It includes an overview of the physical and logical network diagrams. It also outlines various network policies for internet access, printing, storage, email usage, user administration, naming conventions, protocols, workstation configuration, network device placement, and security. The security policies address procedures for user accounts, passwords, network access, firewalls, encryption, logging, physical access, intrusion detection/prevention, and vulnerability assessments. Violations of the security policy are also addressed. The network is designed to support 225 users while meeting HIPAA requirements and allowing offsite access.
Iot, cloud and healthcare - Challenges and OpportunitiesArash Ghadar
The document discusses the opportunities and challenges of using IoT, cloud computing, and telehealth in healthcare. It provides several case studies of current IoT applications in industries like oil & gas, food, and medical. Key challenges identified are ensuring timely and reliable data delivery, network and data security, and complex certification processes. The future of telehealth is seen as improving healthcare access and reducing costs through remote monitoring and treatment of chronic diseases, though security and regulatory barriers must still be addressed.
Security Requirements, Counterattacks and Projects in Healthcare Applications...arpublication
Healthcare applications are well thought-out as interesting fields for WSN where patients can be examine using wireless medical sensor networks. Inside the hospital or extensive care surroundings there is a tempting need for steady monitoring of essential body functions and support for patient mobility. Recent research cantered on patient reliable communication, mobility, and energy-efficient routing. Yet deploying new expertise in healthcare applications presents some understandable security concerns which are the important concern in the inclusive deployment of wireless patient monitoring systems. This manuscript presents a survey of the security features, its counter attacks in healthcare applications including some proposed projects which have been done recently.
RTI Connext DDS messaging software helps evolve standalone systems to integrated distributed systems, connect devices to improve patient outcomes, and replace dedicated point-to-point wiring with networks.
A wide range of additional benefits are possible, including improved diagnosis and safety, delegated care or treatment, and smarter machine assistance for healthcare.
Information technology in health care managementmohamedmoosa2
The document discusses various roles of information technology in healthcare management. It describes how IT helps with communication between devices, teams, patients and providers. It enables secure exchange of health information and establishes reputations as stewards of private data. The roles of IT include supporting accurate operations, quality care through reliable technology, and cost reductions through automation. IT specialists discussed include systems analysts, database managers, networking specialists and software programmers. Future IT jobs may involve areas like 3D printing, artificial intelligence and robotics. The document also lists major US and Indian healthcare information system companies.
The document discusses the benefits of mobile device connectivity for healthcare. It notes that over 30% of physicians make decisions with incomplete information, and mobile technologies could eliminate 11-30% of office visits. Remote monitoring is shown to reduce costs and hospital admissions for conditions like diabetes, congestive heart failure, and COPD. Widespread use of remote monitoring for chronic conditions could save over $200 billion in healthcare costs over 25 years. Standards-based WiFi technologies can effectively support remote patient monitoring.
Healthcare IoT and Analytics to treat Parkinsonsrcnossen
Rick Cnossen from Intel discussed transforming healthcare with the Internet of Things (IoT). IoT can help drive outcomes-based payment, wellness programs, reduce costs of chronic care, and help with clinical trials. Intel's vision is to connect computing technology to people worldwide. Wearable devices can help manage Parkinson's disease by continuously tracking symptoms, activity, sleep, and tremors to provide accurate reports between doctor visits. Big data analytics of information from many patients can provide insights to help research and pharmaceuticals. Challenges to address include the lack of objective measures between infrequent doctor visits and the high costs and small sizes of clinical trials.
IRJET- Android base Healthcare Monitoring and Management System using IoTIRJET Journal
This document proposes an Android-based healthcare monitoring and management system using the Internet of Things (IoT). The system uses a body sensor network (BSN) where sensors attached to a patient's body can monitor vital signs wirelessly. The sensor data is sent to a healthcare center via the BSN. The healthcare center then analyzes the data and provides real-time feedback and alerts to patients and their families. This ensures remote patient monitoring and management while improving comfort and healthcare quality. The document discusses the system functionality, literature review on similar systems, algorithms used and security analysis to show how the proposed system addresses security needs in BSN-based healthcare more effectively than previous systems.
The document discusses research on using wireless sensor networks for healthcare monitoring. It proposes using environmental and physiological sensor nodes integrated into wireless networks to remotely monitor human health conditions and environment. This could help build an e-healthcare system that monitors, predicts, and informs medical staff to prevent diseases while not interrupting daily activities. The system aims to link human health with environmental monitoring for a holistic view of well-being. Future work includes further development of tools, system design and implementation, analysis of results, and publishing papers on this research topic.
Killed by code - mobile medical devicesFlaskdata.io
There is a perfect storm of consumer electronics, mobile communications and customer need - the need to help people manage chronic disease like Parkinson, diabetes and MSA and sustain life with pacemakers and ICDs
How Interconnectivity Is Enabling The Future Of Patient-Driven HealthKent State University
1) Connected health technologies like wearables, home devices, and remote patient monitoring apps have the potential to transform chronic disease management by allowing patients to manage conditions at home independently.
2) Remote patient monitoring is increasingly being used to monitor chronic conditions like congestive heart failure and is showing success in reducing hospital admissions. Technologies also support healthy aging by enabling aging in place.
3) While connectivity offers opportunities, deploying and managing these systems poses challenges for providers and patients regarding technical support, data security and privacy, and maintaining remote monitoring equipment.
- Bethesda Medical Center will be a private specialty teaching hospital in Port-au-Prince, Haiti providing emergency, inpatient, and outpatient consultative services. It will have a North American-Haiti partnership structure and teaching faculty.
- The technology architecture principles focus on reducing complexity, using low-cost and open solutions, leveraging cellular infrastructure and smartphones, and standardizing data formats.
- The document outlines the technology architectures for local sites, regional centers, the hospital, and a future provider tele-health monitoring system. It emphasizes using minimal local infrastructure and cellular or cloud-based solutions where possible.
Fundamentals of Medical Device ConnectivityNuvon, Inc.
I this three part series, John R. Zaleski, PhD, CPHIMS, Vice President of Clinical Applications & CTO of Nuvon, Inc. discusses 3 areas of Medical Device Connectivity beginning with the Fundamentals, to Clinical Decision Support, and next generation Mobile Device Connectivity.
The document discusses how the Data Distribution Service (DDS) middleware standard can enable integration of medical devices and systems. DDS allows devices and applications to share information through a global data space and supports real-time performance, reliability, and interoperability across platforms. Examples shown include using DDS for integrated control of medical imaging devices like CT and MRI scanners, particle therapy systems, surgical robotics, and connecting monitoring devices at the hospital, ambulance, and clinical levels. DDS provides a common information model and quality of service policies to ensure safe and effective data sharing across disconnected medical systems.
The objective of project is to improve end-users’ Healthcare experience through its IoT-based Healthcare services and to support business incubation scheme with better
regulatory support
Patient Health Monitoring System using IOTIRJET Journal
This document describes a patient health monitoring system using the Internet of Things. The system uses sensors to measure a patient's temperature, heart rate, and other vital signs. The sensor data is sent via Bluetooth or WiFi to an Android smartphone app. The app monitors for any abnormalities and will send alerts to the patient's doctor and relatives if issues are detected. The system aims to allow for continuous at-home monitoring of patients after they leave the hospital to help prevent health issues and speed up response times in emergencies.
Binseng Wang, ScD, CCE – Vice President, Performance Management & Regulatory Compliance, ARAMARK Healthcare’s Clinical Technology Services
Clinical engineering (CE) professionals have realized for some time that the “preventive maintenance” (PM) that they have been performing for many years is no longer able to prevent any failures, although some safety and performance inspections (SPIs) can help detect hidden and potential failures that affect patient safety. To help CE professionals decide whether they should continue to perform scheduled maintenance (SM) or not, a systematic method for determining maintenance effectiveness has been developed. This method uses a small set of codes to classify failures found during repairs and SM (PMs and SPIs). Analysis of the failure patterns and their effects on patients and users allows CE professionals to compare the effectiveness of different maintenance strategies, and justify changes in strategies, such as decreasing SM, deploying statistical sampling, or even eliminating SM.
As the impact of healthcare reform on the U.S. delivery system comes into focus, there is little doubt that it is a “game changer” for clinical engineering and biomedical equipment technology. Carol will describe and discuss the future of the CE and BMET professions under new regulations and a new payment system. She will address why medical devices will cost much more, why equipment must have longer life cycles, why CEs and BMETs will and must have more involvement in IT-related activities, how CEs’ and BMETs’ responsibilities in regulatory compliance will expand and how you can prepare for this new environment.
About Carol Davis-Smith, CCE
Career Summary
Carol Davis-Smith is a Director in Premier’s Consulting Solution Division with responsibility for the development and deployment of capital lifecycle management processes and tools to Premier staff and owners.
Education and Affiliations
Ms. Davis-Smith received a B.S. in bioengineering technology
from the University of Dayton and an M.S. in engineering from the University of Arizona. She is a certified clinical engineer and a member of the Association for the Advancement of Medical Instrumentation (AAMI). Over the past 20 years, she has presented and published papers on a variety of clinical engineering and capital contracting topics. In 2009, Ms. Davis-Smith received the AAMI Clinical Engineering Achievement Award.
eRX Webinar - State Health Information Exchange Leadership ForumBrian Ahier
The document discusses various potential roles that states or state-designated entities (SDEs) can play in supporting electronic prescribing (ePrescribing) to help meet meaningful use requirements. It outlines conducting a gap analysis of ePrescribing capabilities; tracking adoption; developing education campaigns; examining regulations; coordinating stakeholder strategies; engaging pharmacies; updating Medicaid; increasing provider awareness; facilitating electronic prescribing of controlled substances; and monitoring emerging issues. Examples from Minnesota, Rhode Island, Florida and Tennessee are provided.
Risk Management of Medical Devices Connected To IT Networks per ANSI / IEC 8001
Published 2011 for informational awareness, non-profit, non-consulting purposes of publicly available resources.
Disclaimer
This document is made available at this web site for educational informational purposes only. It is not intended for the purpose of providing legal advice or regulatory advise as ISO 8001 was in draft form in 2011 when this document was originally published.
You should contact your attorney and corporate security / risk management officer(s) to obtain advice with respect to any particular security risk issue or problem. No obligations, rights or indemnification is given or implied by the public sharing of this document. Use of and access to this document on this Web site or any of the e-mail links, materials, etc., contained within the document do not create an attorney-client relationship, consulting between the author(s), legal and / or medical risk management advice in any context between the user or browser.
The opinions expressed at or through this site are the opinions of the individual author to the best of public knowledge in 2011 only. Therefore it does not reflect the opinions of any firm, ISO 8001 committee or any individual attorney or legally binding statue, regulation,etc.
This document summarizes information about various biomedical equipment technician associations. It discusses national associations like AAMI and ACCE. It also describes several regional associations like CMIA in California, NCBA in North Carolina, and BMETS in Baltimore. Finally, it provides advice on starting a new local association, including incorporating, getting nonprofit status, developing bylaws and a board, creating a website, and planning membership meetings and educational events.
High Frequency Jet Ventilation was developed in the 1970s and 1980s as a new ventilator strategy for premature infants. It uses small tidal volumes at high frequencies, between 10-15 Hz, to oxygenate and ventilate the lungs while avoiding damage from larger tidal volumes. Early experiments showed convection and diffusion could penetrate the lungs with small tidal volumes if delivered rapidly enough. This led to the development of the LifePort ventilator adapter, which uses a jet injector port and short inspiratory times to create transitional gas flow through the lungs without becoming turbulent. High frequency jet ventilation is now widely used globally and has improved outcomes for premature infants.
Jambey Clinkscales gave presentation on "The Value of Cloud in the Business Technology Ecosystem" at the 2011 BDPA Technology Conference in Chicago.
Jambey shared his thoughts on the workshop during BDPA iRadio Show interview held on August 28, 2011 --> http://www.blogtalkradio.com/bdpa/2011/08/29/bdpa-iradio-workshop-presenters
Workshop Presenter:
Jambey Clinkscales
Capabilites and Program Manager, HP Enterprise Services
Topic: The Value of the Cloud in the Business Technology Ecology
BDPA New York Chapter
Este documento menciona varias cosas que le gustan a la persona como compartir el día a día con gente cercana, atardeceres, un lugar para desconectarse, tomar cerveza con espuma, vistas favoritas como una plaza del pueblo donde vivió momentos y helados que le apasionan.
This document is a training report submitted by Ambrish Kumar Shukla to Krishna Institute of Engineering & Technology in September 2013. It provides an acknowledgement thanking his training guide Pratibha Gupta and the employees of ALTTC for organizing the vocational training program. It then outlines the objectives and scope of the training, which was to learn about various technical areas of telecommunications including fundamentals, broadband, GSM, CDMA, satellite communications and more. The report includes a table of contents covering topics like broadband, WiMAX, power line communication, free space optics, GSM and CDMA.
El documento presenta una breve cronología de la historia de la humanidad dividida en cuatro períodos: Prehistoria (hasta el 300 a.C.), Edad Antigua (hasta el 456 d.C.), Edad Media (hasta el 1453 d.C.) y Edad Moderna/Contemporánea (hasta nuestros días). La Prehistoria se subdivide en Paleolítico, Mesolítico y Neolítico, así como la Edad de los Metales incluyendo Cobre, Bronce y Hierro.
Apple Leaf is an independent science-based consulting firm that provides agricultural services to growers to help them gain a competitive market advantage through improved crop health, yields, and financial returns. The firm offers services in integrated pest management, food safety, farm production management, and whole farm planning to growers of fruits, vegetables, and greenhouse crops throughout North and Central America.
Network embedded management and applicationsSpringer
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Tags: Information Security, ISO/IEC 27001, ISO/IEC 42001, Artificial Intelligence, GDPR
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Philips Implementing Wireless in the Hospital Enterprise: Medical Device Considerations and an Update on IEC 80001
1. Implementing Wireless in the Hospital
Enterprise: Medical Device Considerations
and an Update on IEC 80001
Olivia Hecht, Philips Healthcare, olivia.hecht@philips.com
Olivia Hecht, Philips Healthcare, olivia.hecht@philips.com
Phil Raymond, Philips Healthcare, phillip.raymond@philips.com
Rick Hampton, Partners Healthcare, RHAMPTON@PARTNERS.ORG
2. Agenda
• Common Wireless Applications in Use Today
• The Need to Define a Wireless Strategy
• Wireless Technologies Overview
– DAS for infrastructure
– WMTS
– 802.15 Short Range Radio
– 802.11 Wi-Fi
• Medical WLAN High Level Design Steps
• How IT and CE departments can support wireless technology
• IEC 80001: An Update
• IEC 80001-2-x Wireless Guidance Technical Report Overview
– Medical IT-Network Wireless Strategy Overview
• Q&A
2
3. Wireless Applications in Healthcare
Applications • Communication enhancements
• Location based services – Event management
– Asset tracking (e.g. Secondary alerting)
– Push to talk communicators
• Voice over IP over Wi-Fi
• Workflow enhancements
• Paging Room
Cisco 7925
202 – Spot checks with a direct feed out HL7
• WoWs V-TACH
– Remote data viewing for improved
• Bedside charting consultation
• Wireless spot check monitoring – Temperature sensors eliminating
• Wireless sensing and control for lighting clipboards
and HVAC systems • Improved resource utilization and
• Short range connectivity between body productivity
sensors and monitoring devices – Community hospitals leveraging
intensivists at remote sites
– Electronic data feeds for EMR/EHR
– Asset location
3
4. What’s the Hospital’s Wireless Strategy?
• Mapped out plan in concert with IT, RF Manager (if applicable)
• Consider things such as:
– What systems and spectrum will the hospital deploy?
– Is the facility providing staff with cell phones?
– Capacity required (across the spectrum) and coverage necessary, now and
down the road for all systems
– Number of services expecting to support; potential for conflicts
– System scalability
– Total cost of ownership
– Who is maintaining life critical network? Discrete system vs. integrated into
a DAS?
– Repair/maintenance strategies, vendor support and risk management
Confidential 4
Divison, MMMM dd, yyyy, Reference
5. Distributed Antenna Systems in Healthcare
• Good for bringing wireless WAN (e.g. cellular)
into buildings
• Differences in compatibility with discrete Wi-Fi
architectures
• Active vs. Passive
• Scalability potential issue for future
capacity/BW expansion
InnerWireless Horizon DAS
5
6. WMTS Technology Considerations
• Frequency and physical separation
with use of protected spectrum
• Integration of WMTS wireless
network into existing wired
infrastructure
• Can be compatible with some DAS
systems
• 608 MHz band with migration to 1.4
GHz band
• ASHE registration required
6
7. Short Range Wireless Technologies
• 802.15.x family of PHY & MAC layer architectures
– Info: http://ieee802.org/15/index.html
– 802.15.1 Bluetooth (WiBree)
– 802.15.4 ZigBee focus
– 802.15.6 Body Area Networks
• Applications include sensor networks, Bedside wireless ecosystem,
Health & Well-Being
• Spectrum usage varies (unlicensed but MBAN potential)
• Most implementation, configuration and management is built-in
7
8. Wi-Fi and 802.11:
Challenges and Recommendations
Major Challenges
• Use of unlicensed spectrum & non deterministic device access
Recommendations
• Use WMM (QoS)
– Segregate traffic based on priority access
• Utilize both bands of spectrum (2.4 & 5 GHz)
• Take advantage of networking vendor capabilities
– Visibility into, and monitor the network health & usage
• Be aware of network vendor proprietary extensions
– Are your devices compatible with proprietary functions
• Read and follow IEC 80001-1 & 80001-2-x Wireless Guidance TR
8
9. Step-by-Step Wireless LAN Design
1. Determine the networking capabilities of the medical device
– Wireless technology, spectrum usage, QoS, etc.
2. What are the networking performance requirements of the medical
device?
– Protocols used, latency, signal strengths, etc.
3. Match the wireless networking performance requirements of the
Medical Devices and Systems to the existing capabilities of the
general purpose IT network and identify gaps or incompatibilities
4. Define the clinical functionality in the use and support of the medical
devices
5. Create the clinical SLA by mapping the clinical functionality to the
network design
9
10. Step-by-Step Wireless LAN Design
6. Identify and implement risk mitigations. Many risk mitigations are very
much like ‘best design practices’, but are documented, applied, and
verified as part of the risk management process
7. Design and configure the network(s) to match the most stringent SLAs
of all devices (medical and non medical)
8. Perform pre-GoLive and live network testing to verify that all devices
properly coexist while maintaining their particular SLA
9. Use operational measures to monitor and manage the network such
that SLAs are continuously being met.
10. Policy and procedure implementation; e.g. change control process
11. Read and follow IEC 80001-1 & 80001-2-x Wireless Guidance
Technical Report
10
11. Questions to ask the Wireless Network Manager
• What spectrum is being used or planned in the hospital
– E.g. 2.4 GHz ISM, 5 GHz U-NII, Cellular, Protected (WMTS)
• What types of devices are currently on the wireless network
– General purpose, Voice communications, medical devices
• How are the current or proposed devices used
– Mission critical, guest access, life critical
• How are devices and traffic segregated, prioritized & managed
– SSID, security, infrastructure, QoS
• What are the network support response times
– Is there a focus on clinical requirements on response times
• What are the network change control procedures
– Are they documented?
11
12. ISO/IEC 80001-1 Overview
• A voluntary, international standard applying a risk management process for IT
networks incorporating medical devices (a Medical IT-Network)
– Spanning operational phases from planning to decommissioning
– Sibling documents called “Technical Reports” for further details
• Three “Key Properties” – Safety, Effectiveness, Data & System Security
• Creates a “Responsible Organization” that establishes a “Risk Management
Process” and appoints a Risk Manager that maintains a “Medical IT-Network Risk
Management File”
• Accompanying Technical reports (TR):
– Wireless Guidance TR
– Healthcare Delivery Organization Guidance TR
– Security TR
– Step by Step Risk Management Process TR
– Other… 13
13. IEC 80001-1 Standards Model
IEC ISO
SC62a TC215
JWG7
80001-1 80001-2-x
80001-2-xx
High reference to:
•ISO14971: Medical device Mfr Risk Management process
•IEC 60601-1: Medical device basic safety and essential performance 14
14. IEC 80001-1 – Status
• Preliminary stage Preliminary work item
• Proposal stage New work item proposal
• Preparatory stage Working draft
• Committee stage Committee draft
• Enquiry stage Enquiry draft IEC/CDV
Sept 2010 • Approved final draft International Standard FDIS
Late 2010 • Publication stage International Standard ISO/IEC
15. IEC 80001-1 Responsible Organization
RESPONSIBLE ORGANIZATION
TOP MANAGEMENT responsibilities
• Executive Mgmt or C-level
Policies for
• Establish policies • RISK MANAGEMENT PROCESS
• RISK acceptability criteria
– Change/event management • Balancing the three KEY PROPERITIES with the
mission of the RESPONSIBLE ORGANIZATION
• Assigns resources
– Appoints Risk Manager
Resources
• Creates accountability
• Provision of adequate resources
– Multi-organization interaction • Assignment of qualified personnel
• Appointment of the MEDICAL IT-NETWORK RISK
• Documentation MANAGER
• Enforcement of RESPONSIBILITY AGREEMENTS
– Defines responsibility agreement
RISK MANAGEMENT PROCESS
• Clear connection to other PROCESSES
• Ensuring continuing suitability and
effectiveness
• Reviewing results at defined intervals
16
16. IEC Risk Manager: Front and Center
• Reports to RO Mgmt
The RESPONSIBLE ORGANIZATION
• Establishes and manages Risk
Management file TOP MANAGEMENT
Clinical Area
• Engages and works with CE, of expertise
Appoint
rts s
pe de
to
ex rovi
Biomed, IT/IS, HIT vendors, MDM, Biomedical
Gu
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id
Engineering
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es
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ov
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itie
Network vendors expertise
ert s
Ap
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exp vide
so
Processes
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f
Procedures
s
IT area of
ide to expertise
ov
• Assists in establishing processes, Sup
erv
ises
cre
MEDICAL
IT-NETWORK
RISK
Pr erts
e xp
atio
no
policies and procedures MEDICAL IT-
NETWORK RISK
Risk
f MANAGER Provides
experts to
Other...
MANAGEMENT
Management
FILE
• Event management coordination
to
File
Provides input to
put
Pro
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Residual Risk
vide
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and documentation
inpu
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Sub-
Medical Medical contractor
device device
manufacturer manufacturer
or provider of or provider of
other IT other IT
technology technology
A B
17
17. IEC Risk Management Documentation
• Risk Management file is for documenting the process and results
– Risk Management Process or Plan
– IT network documentation
– Risk analysis & associated measures
– Medical device or software assets
• Responsibility Agreement
– Defines responsibilities and interdependencies
– Involves Medical device manufacturer, networking vendor, hospital
admin
– A contract (e.g. may start with RFP, etc.)
18
18. Biomedical & IT Convergence
• Network design & • Clinical functionality
Expertise • medical device
• Network processes, configuration
policies and maintenance • Medical device maintenance
IT/IS CE/Biomed
CE
IT
Network
MDM
Vendor
• Medical device • Network & Component
networking performance capabilities
specifications • Design & Configurations
Engages and works with Clinicians, Biomed, IT/IS, HIT vendors, MDM, Network vendors, etc.
Opportunity for converged skill-set – Biomedical, HIT, networking (wired and wireless)
19
19. IEC 80001-2-x Wireless Guidance Index
• 1 Introduction
• 1.1 Organization of the technical report 3
• 1.2 Clinical Functionality and Use Case 4
• 1.3 Wireless Guidance and Risk Management 4
• 4 Wireless Medical IT-Network: An Introduction 7
• 4.1 MEDICAL DEVICE Networking Traffic Profile 7
• 4.2 Enterprise MEDICAL IT-NETWORK 7
• 4.3 Wide Area MEDICAL IT-NETWORK9
• 4.4 Distributed Antenna Systems 10
• 5 Wireless MEDICAL IT-NETWORKS: Planning and Design
• 6 Wireless MEDICAL IT-NETWORKS: Deployment and Configuration
• 7 Wireless MEDICAL IT-NETWORKS: Management & Support
• 8 General RISK MITIGATIONS
20
20. Wireless Guidance
Overview Example
Risk TR Focus
Management Identify Hazard
(not addressed in Loss or impairment of
Wireless TR) Wireless connectivity
Identify Cause &
hazardous sit’n
Estimate Risk
Involves wireless network
Identify Risk
Mitigations planning & design,
deployment, management
Residual Risk
Evaluation and monitoring;
Policies and processes
Implement Risk
Mitigations
Pre-GoLive testing
Verify Mitigations
Residual Risk
Evaluation
Risk Mgmt Report
21
21. IEC 80001-1 Risk Mgmt Process
• Map a risk management process into clinical terminology
Hazardous
Hazard Cause
Situation
Risk Patient Risk
Mitigations Harm Analysis
22. IEC 80001-2-x Wireless Guidance
• Example applying risk management wireless networking
Missed Treatment
(Sentinel Event) Ex. AP Outage Loss of Alarm
Network
Clinical Hazardous
Failure
Hazard Situation
Cause
Severity &
Mitigations Harm Impact Probability
Est.
Patient Injury Catastrophic &
Med. Probability
23. IEC 80001-2-x Wireless Guidance
• Example applying risk management wireless networking
Missed Treatment
(Sentinel Event) Ex. AP Outage Loss of Alarm
Network
Clinical Hazardous
Failure
Hazard Situation
Cause
Severity &
Mitigations Harm Impact Probability
Est.
Patient Injury Catastrophic &
Low Probability
Add RF Redundancy
24. Medical IT-Network Wi-Fi Strategy
Vendor Site Specific Guidance
Specific
Wi-Fi Wi-Fi Specific Healthcare
Knowledge Guidance
Wireless Wireless Technology &
Guidance TR Risk Mgmt Convergence
HDO Risk
IEC 80001-1 Management Process
25