Enabling revolutionary progress
Dr. Royth von Hahn, Senior Vice President of Medical and Healthcare Services at TÜV SÜD notes, “The miniaturisation of technology components combined with increased computing power and connectivity is making medical devices with software components more accessible and compatible with mobile use.”
The value of the medical wearables market is forecasted to hit US$14.41 billion by 2022. This growth is fuelled by a shift in the usage of wearables from tracking steps to monitoring medical conditions in real-time.
Consumer devices are making the leap from being a personal health wearable device to a patient care companion used with one’s smartphone. The latest edition of the smartwatch can produce electrocardiogram (ECG) scans. These ECG scans can monitor a user’s heart rhythms and alert them when rapid or irregular heartbeats are captured.
These changes are making it possible for healthcare providers to carry out remote patient monitoring and prevention, which can reduce the likelihood of hospitalisation and the need for expensive treatment.
While the health and wellness benefits of these medical wearable devices are clear, the inherent risks of data security and privacy breaches remain a major concern. Even if the security functions on these devices can prevent data security breaches, the companion smartphone application and cloud services containing patient data may not.
In order to allay these concerns, Dr. von Hahn explains that, “Companies must work to expand their pool of experts with IT security expertise to maintain the integrity of these applications.”
Besides wearables, the trend of miniaturisation and increased computing power is contributing to the popularity of neuromodulation medical devices. These devices can alter nerve activity and function by delivering a targeted stimulus to specified neurological sites on the body. Its potential impact could range from reducing tremors for patients with Parkinson’s disease, to enabling wheel-chair bound patients the possibility to even walk.
However, safety and security concerns about the consequences of device failure or risk of implantation infection remain. Additionally, there are ethical concerns about utilising such new technologies not only to address medical conditions, but also for human enhancement. To this end, Dr. von Hahn cautions, “The onus for regulating the use of such devices lies with society to demand for increased ethical review.”
With more connected medical devices being used, healthcare providers and patients are now confronted with a wealth of health data collected.
The good news is AI is enabling the analysis of the data collected at a depth that is not available with current technologies. Dr. von Hahn notes, “The algorithm-based data analysis capabilities of artificial intelligence technologies are also allowing for new applications of these technologies to be developed.”
AI technologies are also being included in medical devices to evaluate and diagnose patients without human intervention. For instance, imaging machines with AI capabilities can now review and translate mammograms at a faster and more accurate rate, reducing the need for biopsies.
However, some problems remain around the likelihood of erroneous diagnoses made by AI-powered devices and the difficulty in ascertaining which party is responsible for the medical advice. As such, more research and development still needs to be done to improve the accuracy of diagnoses made by machine learning systems.
Additionally, for self-learning systems, the traditional approach of safety standardisation is no longer appropriate since they are constantly evolving with further inputs over time. However, the traditional approach relies on a deterministic approach.
The greater adoption of smart healthcare technologies, like blockchain-based patient databases and cloud solutions, has created unprecedented breakthroughs in patient data security.
Healthcare providers adopting blockchain databases do so because it allows them to access a patient’s complete and updated medical record with ease even if they have been to multiple healthcare providers. As they are decentralised systems, patient data is stored and distributed across a peer-to-peer network, which is kept in sync continuously. Such databases also use an algorithm-based authentication process to reduce unauthorised access hence increasing data security and patient control over their own medical records.
Cloud databases are another predominant type of storage being used to keep patient information as it enables data to be shared across healthcare providers in different locations. These databases also allow companies to avoid suffering losses in the event of physical damage to its devices.
A renowned chain of general practice clinics in Germany, Wolfart Klinic, migrated its patient data to Sealed Cloud’s iDGARD product to safeguard against hackers. With the use of iDGARD, a cloud database system, patient information is always transferred and processed using industry-leading class III encryption protection. This means the system doesn’t just meet industry standards but is also compliant with governmental regulatory rules.
Network access is also fundamental to ensuring that the integrity of both cloud-based and blockchain databases can withstand cyber attacks and hackers. A single data breach incident could cost healthcare organisations up to US$3.86 million. As such, it is imperative for companies to develop or adopt robust information security management systems to avoid costly damages.
Roche Diagnostics International, a healthcare diagnostics company partnered TÜV SÜD to establish a defined information security management system based on ISO 27001, which governs the use and access of highly sensitive patient information. TÜV SÜD’s auditors were also on hand to offer their professional input and share their deep knowledge in the field throughout the process. This allowed Roche Diagnostics International to gain incredible insights and tools to set up their own information security systems.
As there are currently no international standards for the cyber security of medical devices, TÜV SÜD, together with the Johner Institute and other industry partners, have developed an open guidance document on cyber security, providing the most relevant conformity requirement information.
Additive manufacturing has positively impacted the medical device industry, with potential to reshape patient care services by producing personalised healthcare treatments.
At its core, additive manufacturing is about turning computer-aided designs into objects by applying heated plastic or metals. While it is often associated with parts manufacturing, these technological advancements are enabling doctors to customise and manufacture medical implants. More complex and anatomical conforming implants can be created. Applications include spinal implants, joint replacement as well as trauma implants.
These manufactured implants can be customised, its best-fit design enabling greater functionality. Lead times for customised implants can also be shorter by using additive manufacturing at the hospital. This allows them to be applied sooner, especially for time sensitive injuries such as fractures.
However, current product standards do not consider additive manufacturing as a production method. This raises concerns about the safety of additive manufactured implants compared to traditionally manufactured implants. Lack of substantial data tracing the use of 3D printed implants and its experiences with patients also makes it difficult to draw a definitive conclusion on its added value.
The adoption of smart healthcare products and solutions will gain momentum over time, resulting in unprecedented breakthroughs for patients and healthcare professionals alike. However, as IoMT ultimately involves people and their health, safety and security must be the top priority.
Dr. von Hahn points out, “As new and innovative healthcare technologies become commonplace, companies and regulatory bodies within the medical device and healthcare space must be aware of safety concerns to mitigate risks and harness new growth opportunities. Patients’ safety and wellbeing must remain at the heart of innovation efforts in order to drive the adoption of new technology.”
At TÜV SÜD, companies can find a trusted testing and certification partner for the safety of technological advancements — a vision that we have stayed true to for over 150 years.
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