Dr Google approved AI in Primary Care.

There is much excitement of the role of AI in diagnosing disease, especially as its capabilities are starting to equal and increasingly often surpass the experts, AI is intended to supplement and assist. But that excitement does not extend to AI in Primary Care, where AI is all but absent. Yet it is in Primary care where AI's potential could provide the greatest benefits to Patients, in part by augmenting and extending a clinician's abilities to diagnose.

Recently one of the first AI based device cleared by FDA for use in primary care, was peer criticized for its clinical limitations - it could only diagnose a single disease. Also, peers could not understand how a $18,000 piece of medical equipment that was also needed, that could diagnose a single eye disease condition, be “for-use” in Primary Care. The criticism also extended to the fact that the “autonomous” diagnosis related only to the possibility of this disease beyond its minor presence.

The peers understood that although effective for that one specific disease condition, the patient would be mis-lead into believing everything was “ok”, when they could in reality be suffering from the many other eye related diseases that were not ruled out, not supported by that device.

No matter how clear the disclaimers to that effect, patients simply will never understand that limitation – they want to believe the device has absolute powers!

Specialised single disease diagnostic devices are “dangerous” for use in Primary Care, whether AI based or not. They can be easily misunderstood and misused as they are too specialized, too limited and too expensive to effectively provide widespread screening benefits to potential patients. They don’t provide a comprehensive answer, as expected by patients.

And, in the age of “Dr. Google”, patients believe they are extremely health savvy, sometimes for the good, sometimes not! These internet doctors spread not only generalist health advice, but mainly also fear. It is this fear that drives patients to diagnostic medical devices to provide the medical “truth”. Single or limited first use devices in Primary Care don’t always measure up.

The best but little-known example of a limited diagnosis device which is widely used in Primary is the ECG! Surprised

Don’t be, you’re not alone. Few understand the limitations of ECG, which because of its electrical nature is seriously limited in functionality as it can only detect diseases that have an electrical signature. This means it is limited to about 44% of all common heart diseases, and this only when AI and algorithmically augmented.

This is why most Standards of Care, a cardiologist must “over-read” the ECG before the clinician can discuss it with the patient. Basically, the medical community is admitting that ECG is only effective on less than ½ of all common heart diseases.

No surprise therefore that is has not been adopted for the widespread screening of patients in Primary Care – able to detect only ~44% of all common heart disease, its simply not suitably effective – and that makes it dangerous!

It continues to be used because for the diseases it can detect, it does it really well. But mainly, it continues to be used for lack of a any better device for decades.

Now enter AI in Primary Care, and see a positive example:
Cardio-HART™ or CHART for short, is an AI powered, first-use, non-invasive, diagnostic system that together with the FDA cleared Cardio-TriTest™ device, provides clinicians with a better more complete understanding of a patient’s overall cardiac status - because it can detect and diagnose ~94% of all common heart diseases.

94% is “the” definition of clinical effectiveness, especially for Primary Care. 

Designed essentially for us in Primary Care, Chart outputs a broader range of disease findings and parameters than ECG. CHART provides 64 findings and 167 heart parameters, including all those provided ECG.

No other single diagnostic device in existence today can provide such a wide-ranging scope of cardiac status for use in Primary Care.

With 1 in 3 Americans at risk of heart disease and combined with an aging population, AI can supercharge Primary Care and provide patients with proper CHART.

Dr Google would approve.

Cybersecurity and Ecosystems of Medical Devices - Best approaches and strategies

Ensuring medical devices are safeguarded from cyber intrusions is a shared responsibility across the medical device ecosystem. As medical devices become more digitally interconnected and interoperable, they can improve the care patients receive and create efficiencies in the health care system. However, medical devices, like computer systems, can be vulnerable to security breaches, potentially impacting the safety and effectiveness of the device. Thankfully, manufacturers can adopt a holistic approach towards reducing cybersecurity risks associated with devices and of concern to patients by carefully considering — and building in — cybersecurity during design and development of medical devices, as well as having a robust postmarket plan to both manage emerging cyber vulnerabilities and to respond to intrusions or exploits affecting device performance when they occur.

Applying a best-teams approach

The FDA’s role and commitment to medical device cybersecurity continues to increase in scope and nature as they consider the implications of compromised devices across their total product lifecycle.
In the past 5 years they worked towards the vision of a healthy and resilient cyber ecosystem, that dream is now even closer, this month FDA has taken a ongoing relationship with the U.S. Department of Homeland Security (DHS) to another level. They announced a memorandum of agreement between the FDA and DHS, to implement a new framework for enhanced coordination and information of
cybersecurity vulnerabilities and threats. This could lead to more timely and effective responses to potential threats to patients safety and public health.

DHS serves as the central medical device vulnerability coordinating body and interface with appropriate stakeholders, including consulting with the FDA for technical and clinical expertise regarding medical devices. DHS' National Cybersecurity and Communications Integration Center will continue to coordinate and enable information sharing between medical device manufacturers, researchers and the FDA. The FD will continue to engage in regular, specific problems and emergency coordination calls with DHS and advise them regarding the risk to patient's health and potential for harm posed by the cybersecurity threats and vulnerabilities.

FDA is proactively addressing the risk to medical device in the face of an evolving cyberthreat with a release of the premarket cybersecurity guidance update. This was done to better protect devices from compromise; maintain device functionality in a safe mode even in the event of an attack and reduce potential risk to patients.


Although the FDA issued guidance providing recommendations for device cybersecurity information in premarket submissions in 2014, the rapidly evolving landscape, and the increased understanding of the threats and their potential mitigations necessitated an updated approach. They will hold a public Workshop in January 2019, to discuss the draft guidance “Content of Premarket Submissions for Management of Cybersecurity Medical Devices.”

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Building strategic alliances

Creating an environment of shared responsibility means seeking out new engagements — formally and informally — with diverse stakeholders, including other government agencies, industry, healthcare delivery organizations, cybersecurity researchers and more. These relationships have provided FDA with insights into complex, device lifecycle challenges; they have also brought forth opportunities to leverage potential new tools and multi-pronged approaches to mitigate current gaps.

In the recent news MITRE, a non-profit corporation with support from the FDA, released a Medical Device Cybersecurity Regional Incident Preparedness and Response Playbook that can serve as a customizable tool for health care delivery organizations to aid in their preparedness and response activities for medical device cyber incidents.

Another example of FDA efforts to advance and support regulatory science for medical device cybersecurity is a participation in the Medical Device Innovation Consortium (MDIC). This non-profit, public-private partnership brings together industry, government, professional societies and advocacy organizations, to add value to the intersecting needs of the medical device industry, to promote the total product lifecycle of a medical device and to improve patient access to innovative products.

On October 1st, MDIC released a report on medical device cybersecurity and advancing coordinated vulnerability disclosure. This report advances an incredibly important topic in medical device cybersecurity  — the adoption of coordinated vulnerability disclosure policies and processes.
Knowing this information is critical, this way FDA can address the cybersecurity risk to medical devices in a timely and coordinated manner.

Another notable partnership is the FDA’s participation in the Healthcare and Public Health Sector Coordinating Council (HSCC). This HSCC task group will be releasing a Joint Security Plan this fall that describes best practices for implementing medical device cybersecurity and resilience recommendations, and further demonstrates the capabilities of medical device manufacturers working together with healthcare provider organizations to articulate a common vision to further safeguard patients.

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FDA has showed a unwavering commitment to making cybersecurity a top priority for the agency, additional resources have been requested to continue building medical device cybersecurity program. In their Fiscal Year 2019 Budget, they proposed to create a Center of Excellence for Digital Health. This Center of Excellence would help establish more efficient regulatory paradigms, consider building new capacity to evaluate and recognize third-party certifiers, and support a cybersecurity unit to complement the advances in software-based devices.

The importance of establishing and maintaining a robust, collaborative framework for medical device security can be read in the report issued by the Office of Inspector General here.
The FDA has been and continues to work with the medical device industry and other stakeholders to proactively address emerging The FDA has implemented several of the recommendations in the OIG report. Like the evolving nature of the devices regulated — and cybersecurity threats faced — the FDA’s regulatory approach is not static.

This work will continue to drive advances in the increasingly complex medical device ecosystem enabling them as a collective to better anticipate cybersecurity risks and apply mitigation strategies early in the total product lifecycle of a device as well as with increased agility throughout the device lifespan as is necessary.

While National Cybersecurity Awareness Month has just concluded, Presidential Proclamation calls upon government and industry to work together, share information, build greater trust, and lead the national effort to protect and enhance the resilience of the Nation’s cyber infrastructure.

Source of this Article: FDA Medical Device Ecosystem and Cybersecurity