In May 2017, the first documented ransomware assault on networked medical equipment happened. The worldwide ransomware assault WannaCry compromised radiological and other instruments in several hospitals during its height, after a software failure caused by a cyberattack on its third-party vendor's oncology cloud service, cancer patients having radiation therapy at four healthcare institutions had to reschedule appointments.
These examples show how cyberattacks and data breaches may have a significant impact on the healthcare industry, heavily reliant on connected medical equipment. PHI (patient health information) captured and stored in these connected medical devices must be secured. Because PHI is transferred over the cloud via server-based systems, making it very susceptible to hackers.
Ransomware attacks on health care professionals have become more common, sophisticated, and severe in recent years. Individual bad actors have been supplanted as the main perpetrators by organized criminal gangs, nation-states and military groups. Despite great effort, law enforcement and government have been unable to stop the escalating wave of attacks on hospital devices and other key infrastructure. Medical device security will be a key part of hospital cybersecurity as ransomware attacks on healthcare organizations increase.
Medical Devices have Grown In Scale
The safety of external medical equipment, whether fixed, implanted, or wearable, is critical to patients' lives and well-being. Life-saving medical devices include insulin pumps, heart defibrillators, artificial cardiac pacemakers, and ventilators, to name a few. Examples include artificial joints, MRI and CT scanners, infusion pumps, clinic programming, and home monitoring.
In a hospital or healthcare institution, security cameras, RFID readers, point-of-sale systems, and guest access cards should all be safeguarded from cyber attacks and security breaches. Medical equipment frequently includes computer systems and networks.
In today's world, medical equipment is linked to all other connected devices in a hospital or medical care institution. Built-in sensors in linked medical equipment collect data that may be sent to other devices and the Internet. These gadgets and their data make up the Internet of Medical Things (IoMT), which assists in the diagnosis, monitoring, and delivery of medicine.
These ransomware attacks on medical devices demonstrate the impact of cyberattacks and data breaches on the healthcare business, which is highly reliant on linked medical equipment. Patient Health Information recorded and stored in these linked medical devices must be protected. PHI is sent via server-based systems over the cloud, making it highly vulnerable to hackers.
The connected medical devices, which significantly improve patient care and provide better patient outcomes, should be maintained and upgraded to ensure patient safety from the design stage to their use in healthcare organizations or at home.
The IoT ecosystem consists of medical device manufacturers, providers, systems and software providers, system integrators, connectivity providers, and end-users. More collaboration between stakeholders to tackle the cybersecurity vulnerabilities and risks of connected medical devices will help prevent cyber attacks.
Ransomware assaults on healthcare institution networks trigger medical device outages that put patient lives at risk. You can't have safe and functional medical equipment if it's unavailable due to ransomware. There has been a significant shift in the Medtech sector over the last decade to identify the rising cyber threat to devices. Nation-states and organized crime syndicates are wreaking havoc on medical equipment, jeopardizing their safety and efficacy for healthcare providers.
In a Ponemon Institute poll, a quarter of healthcare delivery businesses indicated they witnessed increased death rates after a ransomware assault. Health systems are at a higher risk of having a negative influence on patient care as linked medical devices become more widely used. The latest issue for healthcare institutions and the MedTech sector is maintaining the availability of medical equipment in the face of escalating cyber threats that threaten patient safety.
Medical devices need to be designed with security in mind to resist even everyday, run-of-the-mill threats like ransomware. Currently, there is no statutory requirement, premarket or postmarket, that expressly compels device manufacturers to address cybersecurity.
Security measures in the cloud
In the event of a data breach, the healthcare institution, not the cloud services provider, is responsible. On the other hand, Cloud providers must follow stringent security guidelines. FDA Cybersecurity Guidelines, cloud security engineering best practices, frequent security audits, disaster recovery scenarios, and action based on a well-defined security and data-protection incident management system are instances of this.
With medical devices or associated software, real-time monitoring, cyber threat modeling and analysis, threat mitigation, and remediation should all be achievable. Due to regular recordkeeping and monitoring, every breach is detected as soon as it occurs. Early detection of a breach helps determine the severity of the breach and ensures that it is remedied.
Medical gadgets, which are frequently obsolete, are not always upgradeable. Assaults on medical equipment with minimal support might cause vital functions to be disrupted, putting lives at danger. Medical device owners should contact the vendor or manufacturer ahead of time if they have any maintenance or update problems with their medical equipment.
The FDA has incorporated a requirement in its Medical Device Safety Action Plan that compels medical device manufacturers to embed security updates and patch capabilities into network-connected devices from the outset, in response to the rising danger.
It also outlines procedures for disclosing any faults in these devices once being released to the general public. It's becoming increasingly critical for engineers to consider cybersecurity considerations while assessing the danger of a medical device. Anti-ransomware/cyberattack protection should be included in the device's specs. If you're submitting one of these devices to the FDA, expect them to ask many questions about how you're dealing with cybersecurity issues.
From the design stage to their usage in healthcare organizations or at home, connected medical devices that significantly improve patient care and improve patient outcomes must be properly maintained and upgraded to guarantee patient safety against ransomware outages.
Medical device makers, suppliers, systems and software providers, system integrators, connection providers, and end-users make up the IoT ecosystem. It will be easier to avoid cyber assaults if all stakeholders work together to address the cybersecurity vulnerabilities and hazards of connected medical equipment.