Addressing cybersecurity for your medical device
Cybersecurity vulnerabilities can emerge in any medical device that can be connected to another electronic device or network.
Reimagining patient-centric clinical trials with the IoMT
There is an opportunity to rethink the clinical trial experience and ultimately bring new treatments to the patients that need them, faster. By using the IoMT to focus on the patient experience, connected technologies are set to revolutionise clinical trials,
Checklist: Addressing cybersecurity for your medical device
Cyberattacks are a complex, constantly evolving global threat. Attacks can disrupt the function and compromise the data security of any medical device that is or can be connected to another electronic device and/or network. In addition, vulnerable medical devices may be harnessed as part of a botnet* to launch attacks on other targets; as a back channel to breach the security of hospital or clinic networks; to extract ransoms; to harm a patient or user of the device and to inflict other financial or reputational damages onto device manufacturers, clinics and patients.
Five steps to successfully incorporate digital health into clinical trials
Recruiting outside vendors has the benefit of accessing best-in-class Digital Health expertise and infrastructure. However, it creates complexity and a need to manage multiple stakeholders and processes. Therefore, every trial design and technology decision – from selecting endpoints to the use of mobile sensors, apps and virtual visits – should be made with an eye toward making trial participation as easy, convenient and rewarding as possible for patients, while collecting the data needed to measure required endpoints. The following steps can help to guide the process of successfully integrating Digital Health technologies into clinical studies.
Innovative mobile health information: The digital diagnosis
As technology continues to evolve, more healthcare providers are turning to mobile healthcare to revolutionise clinical trials and patient care. Harnessing the power and flexibility of mobile devices, mhealth technology provides advantages.
Cybersecurity media articles
The promise of IoMT
Advances in connected devices can inspire innovative clinical trial design including novel ways to collect data, transform and streamline clinical operations and improve the patient experience.
Thwarting cyber-attacks – steps to implement security into mHealth development
Investing in and integrating cybersecurity measures from the beginning of a device and app’s development can go a long way to preventing future vulnerabilities.
How safe design and proactive risk management throughout product lifecycles can mitigate medical and financial risks.
Digital intelligence for the clinical trial: How the IoMT is streamlining clinical operations
Rapid progress in connectivity and technology is inspiring innovative clinical trial design.
How to ensure your trial data and patients remain safe during COVID-19
Adhering to best practices regarding patient data privacy remains important during times of crisis as more sponsors, sites and patients increasingly rely on remote communications.
Improving responses to medical device vulnerabilities
How can manufacturers improve responses to medical device cybersecurity vulnerabilities?
Not if, but when: five cybersecurity threats you can expect:
The FDA, EMA and other regulators consider cyber threats to be so dangerous they now require cybersecurity risk management plans that cover the entire lifespan of new and existing devices.
FDA issues final guidance document on postmarket cybersecurity for medical devices
The US Food and Drug Administration (FDA) is encouraging medical device manufacturers to be more vigilant and build in safeguards throughout the product lifecycle to reduce health and safety risks.
Addressing the inevitable: Managing medical device cybersecurity risks
Regulators, including the US Food and Drug Administration (FDA) and the European Medicines Agency, now require medical device developers to include cybersecurity in risk management programmes.
Personalising digital health
Digital health technologies have the potential to transform the way we conduct clinical trials and generate customised therapies. In fact, they can even inform regulatory decisions. The potential of Digital Health in clinical trials extends beyond transforming trial design and execution, to generating customised therapies using biomarkers and targeted therapies for better patient outcomes.
Transforming medical device development
ICON has identified six critical challenges that present increasing stresses on time-to-market, the efficiency of clinical development, and the overall productivity of a company and its pipeline. In particular, specific and often unaddressed issues in patient recruitment, strategic planning for post-marketing studies, and study protocol design, threaten to undermine the commercial viability of novel medical devices.