Medical Devices

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Medical equipment now can be easily located and maintained. And rental and repair costs are way down thanks to the RTLS.

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The cybersecurity implications of medical devices have come under scrutiny, as the digitisation of healthcare reaches a wider net of professional, personal and public environments. In the bid to consider and plan for an evolving cybersecurity landscape to maintain patient safety, the Therapeutic Goods Administration (TGA) has released a draft regulation guidance on cybersecurity for medical devices, in line with the existing regulatory requirements. The Medical Device Cybersecurity Draft Guidance and Information for Consultation report calls for a clear regulatory environment for connected medical devices and identifies strategies to influence the approaches of those who use medical devices. “Connectivity and digitisation of medical device technologies may help improve or increase device functionality. However, the connection of devices to networks or the internet exposes devices to increased cyber vulnerabilities that can potentially lead to unacceptable risk of harm to patients,” the report identified. “These include denial of service or intended therapy, alteration of personal health data or alteration of device function so that it can cause actual patient harm. “In 2016, the Australian Government released Australia’s Cyber Security Strategy, detailing priority actions to improve Australia’s general cyber security posture, alongside supporting the growth of the local cyber security industry… In line with this, the continued safety, quality and performance of medical devices impacted by cyber-related issues is the responsibility of the TGA.” According to the TGA, operating environments are highly variable and cybersecurity risks are dependent on the knowledge, expertise and approach of the users of medical devices. “A compliant medical device will only be as secure as the most vulnerable aspect of the system it is expected to operate in. Users of medical devices also have share responsibility for providing a cyber- secure environment for these devices to operate in,” the report stated. What is necessary? Key to the implementation of medical devices, according to the report, is the development of a “clear and well documented” risk assessment and business continuity strategy, where the goal is to develop an environment where risk to patients is minimised. It includes an injunction for device manufacturers and users to develop a cybersecurity strategic plan, which includes a cyber-specific risk assessment and response strategies. “The plan should have clearly defined event response procedures that define the responsibilities of each department in the event of an incident, and emphasise the importance of each area being familiar with these procedures,” it said. “The strategy will need to be revised as new types and classes of connected medical devices are added to the healthcare environment.” Cross-functional collaboration is a tool that the report claimed is essential for effective cybersecurity control of medical devices. The TGA said healthcare service providers should aim to facilitate an environment which drives cross functional collaboration between the biomedical, clinical support and IT teams, helping all areas develop a better understanding of the work completed within each team. “The biomedical team should… engage with medical professionals within the healthcare organisation to help broaden their understanding of the operating profile of their devices, the technology under their management, implementation of cyber security controls and the associated risk,” it said. Collaborative procurement is another area for improvement as updating procurement practices to ensure the purchase of appropriately secure devices will create greater demand for improved cybersecurity within medical devices, the report identified. “[One way is to] incentivise procurement teams to work with IT and biomedical teams on the procurement of new medical devices to help ensure that cybersecurity is a measurable factor in procurement.” The report also suggested that organisations develop an inventory and risk profile of the current state of connected medical devices, providing insight to vulnerabilities in the operating environment. This inventory could include information such as the operation and purpose of a medical device, its secondary uses, who the primary users are, expected life-span of the device, support agreements in place and support for critical components. The report also called for more general training for all staff within organisations to raise baseline security awareness and skills. “Many professionals in the health and medical sector have received little training on cybersecurity. [Organisations need to] actively work to create a culture of cyber security awareness, vigilance and reporting, and regularly communicate potential cyber security issues,” it said. Segmenting the corporate network from the biomedical network could also help improve cybersecurity attacks. “Ideally, this should be done with an internal firewall. This will significantly reduce the risk of malware spreading from one network to another. Medical devices should be segmented into logical groups (manufacturer or modality) to reduce the attack surface. When possible, medical devices should be isolated,” the report said. In addition, it recommended that healthcare organisations consider implementing multi-factor authentication for staff access to networks, especially in areas of high traffic, and reduce privileges to only those required.   “Access to the network is critical for most medical devices, especially with an Electronic Medical Record (EMR) system. Ensuring that only authenticated access is provided is key but when credentials are compromised, it can be challenging to define authenticated but unauthorised access. “So, regular reviews of network access should be completed. These must be managed to ensure usability of systems is not adversely impacted.” The report also said that more focus should be given to securing medical devices themselves, instead of just to ICT equipments. “Monitoring the internal and external environment for medical device abnormalities and cyber security threats is important to building a stronger cyber security posture. One advantage of monitoring medical devices is that their range of normal operation is narrow. This means that anomalies can be easier to spot in medical devices than ICT equipment,” it identified. The TGA has invited industry, peak bodies, professional and consumer groups, and individuals to provide comment on the draft guidance. Submissions for comment close on 14 February and will be used to help inform the final guidance document. This article first appeared on Healthcare IT News Australia.

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Healthcare technology took centre stage at CES 2019, with many health gadgets becoming the focus of attention.  One such technology is Charlie, a fully autonomous medical robot that accompanies hospital patients to provide them with comfort. The product of New Health Community, a French startup specialising in digital health, Charlie is equipped with multiple applications and connected devices that aim to respond to patients’ questions and anxieties, reduce their stress and connect them directly with medical staff if needed. By adjusting its functions (via its integrated applications, games and connected objects) to the different needs of each patient, it facilitates the communication process between the patient and its medical team using a video conference application. Charlie is controlled via a smartphone, tablet or a PC, but it can also be used directly via its 24-inch screen. The robot also houses in its body a digital tensiometer, oximeter and stethoscope that patients can use, following instructions from Charlie. The technology adapts to each patient. In the case that a user is visually impaired, it helps the person move around through vocal guidance. For those with hearing disabilities, it gives visual instructions with subtitles (cards, documents, images and videos) to guide them. In the case of speech disorders or autism, Charlie uses a pictogram application to communicate with the patient. And to help those that are wheelchair-bound, Charlie displays the information on the lower side of the screen to be on their sightseeing level. New Health Community Founder Dr Nicolas Homehr told HITNA that as an autonomous indoor robot, Charlie was designed to safely get around a hospital with no help required from humans. “Charlie helps by putting a hierarchy in patient needs. He will save a lot of nurses’ time in running around the service, giving back that one-on-one time that they need with their patients,” he said. “Charlie facilitates communication, educates the patients and allows self check-ups. By doing this, the robot lowers anxiety for the patients and provides relief and help to the staff. “Our patients are isolated and stressed, our nurses often overworked and understaffed. We need to help them all. Hospitalisation is, at some point, a part of everyone's life and we need to make this experience more comfortable. Surgeon robots are here but not nurse assistants, this is why we created Charlie.” VIRTUAL REALITY AS A REMOTE MEDICAL DIAGNOSTIC TOOL FOR SENIORS An ongoing collaboration between VRHealth and AARP Innovation Lab has resulted in the concept creation of an immersive, 360-degree virtual reality environment that aims to remotely solve the issue of seniors accessing quality healthcare. The technology lets seniors give their family members or physicians access to healthcare data collected during their virtual reality therapy sessions, which then allows their caregivers to make the necessary changes to the patient’s treatment. [Read more: Victoria announces cutting-edge robot academy to revolutionise cancer surgery | World’s first cancer app to integrate with an EMR as Australia’s CancerAid links into Cedars-Sinai’s Epic system] As a patient is engaged on the virtual reality device, they respond to tracking tools that conduct a number of exercises, such as brain health applications, cognitive skills, memory span, pain management techniques and neck exercises. From these directed activities, data is then collected, analysed and sent across to physicians and caregivers, reducing the need for in-person visits to the doctor. This technology isn’t a substitute for in-person treatment, but rather, having access to a virtual connection that connects the patient to a healthcare professional may aid in mitigating not only mobility, but also some costs associated with ongoing care. "Our telehealth platform is a crucial step in the healthcare process because it enables patients to engage in a healthcare routine in the comfort of their own home while providing access to their data directly to their doctors," VRHealth CEO Eran Orr said. "Any adjustments that need to be made to a patient healthcare regime can be adjusted based on the data in the platform." Orr also said moving forward, the company is aiming to mitigate issues such as digital privacy considerations and the possibility of misdiagnosis as a result of the medical professional having insufficient inbound data with robust data collection and analysis. A WEARABLE BLOOD PRESSURE MONITOR Omron Healthcare has unveiled HeartGuide, a wearable blood pressure monitor, in its mission of “going for zero” heart attacks and strokes. In what the company calls a global first wearable using oscillometric technology, the device comes as a wristwatch with parts and technology that miniaturise the components for traditional oscillometric measurement and works in the same way that blood pressure cuffs at a doctor's office measure blood pressure. According to Omron Healthcare, HeartGuide uses an inflatable cuff within the watch band to take a blood pressure reading, a key differentiator from other wearables that rely on sensor technology, which it says only provide blood pressure estimates. HeartGuide is able to hold up to 100 readings in memory and all data can be transferred to its new corresponding mobile app, HeartAdvisor. HeartAdvisor then uses the data to help patients better understand their condition, build a more productive patient-to-physician dialogue and gain access to real-time heart health coaching. "Blood pressure isn't static, it's changing constantly throughout the day," Omron Healthcare Executive Director of Business and Technology Jeffrey Ray said. "We wanted to build a device that allowed people to take it continuously throughout the day to understand how the decisions they make actually impact their blood pressure." [Read more: 3D printing implants and organs is the new reality | Here’s how new-age technologies will change patient experience] "More than 80 per cent of heart attacks and strokes are preventable with lifestyle changes. It all begins with regular blood pressure monitoring and achieving better insights into your heart health… This is how Omron is making its mission of ‘going for zero’ a reality,” Omron Healthcare President and CEO Ranndy Kellogg added. In addition to blood pressure, HeartGuide also has some other functionalities of a smartwatch, including email, call and text notifications, as well as sleep and physical activity levels tracking.