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ML in Healthcare – 12 real-world use cases Part 4

Risks and compliance considerations that are particular to AI/ML within healthcare

The ongoing utilization of tech, smart automation and big data within healthcare is a breeding ground for risks and threats.

  • Errors and bias
  • Regulation-related inquiries and investigations
  • Contractual risks
  • Cybersecurity-related hazards
  • Data utilization problems
  • Data privacy – compromises and breaches
  • Operational risks – redundancy and lack of coordination in work across functions
  • Financial risk – lost monetary resources by way of investment and Return-on-Investment
  • Valuation problems – incorrect valuation of services and FMV concerns
  • Informed consent
  • Patient harm

Errors and bias

Bias is native to the healthcare and medical space. One of the latest instances is with regards to pulse oximeters, a critical utility in healthcare practice and a critical utility in the midst of the pandemic. For instance, a majority of oximeters receive their calibration using patients with white skin as the test subjects, and as an outcome, African-origin patients are three-fold more likely than Caucasians to obtain misleading readings, which might influence clinical procedures and outcomes.

The popular smart-wearables manufacturing company Fitbit, has been making shockwaves in the market. It’s foray into heart rate monitors, presently leveraged in more than 300 clinical trials, are additionally less precise on coloured persons. Scores of research demonstrate that females and persons of colour get reduced pain medication, reduced quality of care, and longer time delays to treatment.

Women’s pain and other healthcare concerns are usually misinterpreted by practitioners as being psychological in origin, having the outcome of women who report pain being given antidepressant medication, when they haven’t even indicated feelings or symptoms or depression. The correct course of action is prescribing them painkillers. And similar discoveries have been witnessed for race: “A 2012 meta-analysis of two decades of released research discovered that African-origin patients were 22% less apt than Caucasians to obtain pain meds and 29% less apt to be treated with opioids.

Such biases, one among many, can have the outcome of highly flawed medical data. The observations, decisions, and diagnoses indicated by practitioners are usually regarded as objective, but they are susceptible to errors and gaps, and flawed judgments have the outcome of flawed data. In a majority of scenarios, we don’t possess information directly documenting what patients go through, rather those reports are filtered via a practitioner’s perspectives of their condition. Any ML framework dependent on this data is at risk of substituting these delays, biases, and errors.

To take another critical instance of the way healthcare datasets might systematically misinterpret reality, delays in diagnoses are usual for several conditions, causing incomplete and erroneous data at any single snapshot in time. As an average, it takes half a decade and five practitioners for patients who have autoimmune illnesses like lupus and multiple sclerosis to obtain a diagnosis; 3/4ths of these patients are female, and 50% report being categorized as chronic complainers in the preliminary phases of the condition.

Diagnosis of Crohn’s illness takes up to a year for males and a year and eight months for females, while diagnosis for Ehlers-Danlos syndrome takes almost half a decade for males (at 4 years), and a whopping decade and six years (sixteen) years for females. Just ponder about the number of patients that haven’t obtained a precise diagnosis or who stop trying before ever discovering what’s wrong with them. This leads to unfinished and absent data.

There is additionally a cycle surrounding absent medical information for conditions that are not comprehended well, practitioners have a tendency to not believe patients with regards to their symptoms and overlook them as anxiety of excessive complaining. This causes undercounting the number of people are affected by specific symptoms or illnesses, which in turn makes it difficult to make a case for more funding, the illnesses might stay badly understood and patients are still not taken seriously by practitioners.

Cybersecurity-related hazards

Devs comprehend the requirement for privacy and security in healthcare applications. Within machine learning, a fresh security risk consists of the malicious insertion of erroneous or flawed data into the machine, which can cause invalid or even harmful outputs. Leveraging of ethical hackers, although, can assist in mitigation of the risk of bad data within the domain of supervised learning. These hackers are specialists in simulation of intrusive and malicious actions that cause restrictions or boundaries on system learning, which has the ultimate outcome of safeguarding against bad data.

The hazards of bad data within unsupervised Machine Learning can be minimized by purchasing an established algorithm with embedded mitigation tactics (programmatic, mathematical, etc.) But, a comprehensive analysis of the algorithm mitigations is required by cybersecurity experts who comprehend medical devices in addition to unsupervised machine learning algorithms.

Devs have for long, been on alert with regards to privacy-related problems connected to safeguarded health data in cloud applications. As several machine learning platforms harness cloud storage and thus put forth fresh risks to the procedure, it’s critical for ML developers to comprehend how their information undergoes collation with other data sets. This shared information about the state of the patient could be brought together to violate somebody’s privacy via a strategy referred to as inference by malicious actors. Inference is a strategy that brings together differing innocuous and non-sensitive information to obtain sensitive data.

Take into account the aggregated data with regards to a vehicular accident patient. It’s feasible that a lawyer might slice the information and find out data with regards to the victim’s conditions to place responsibility on the patient for what went wrong owing to a possible diabetic coma. The leveraging of polyinstantiation can reduce these variants of risks by slicing the information into groups for collation purposes, and developing data silos so just the dev is aware of which piece places where on the algorithm, therefore averting the disclosure of the total patient database.

Regulation-related inquiries and investigations

Advanced medical device devs comprehend the well-established procedure for operating with regulators and producing submissions. The hurdle in Machine Learning is with regards to lacking precedence. Regulators are accustomed to operating with established frameworks where a stable and consistent grouping of inputs produces a reliant grouping of outputs, however within Machine Learning, the outputs are experiencing evolution on an ongoing basis. Therefore, devices devs must assist in regulatory agencies determining methods to evaluate the safety and impact of products. Some indicated tactics consist of:

  • Develop a regulatory affairs unit with expertise in Machine Learning and multidisciplinary functions.
  • Conduct early and consistent meetings with regulatory entities so mutual learning experiences may arise.
  • Identify clinical and regulatory data across the planet that assists the desired objective/goal. If negative data is unveiled, tackle it, instead of glossing over it.
  • Don’t get into the habit of submitting ‘black boxes’. Come up with methods to communicate how and why a specific outcome happened.
  • Looked for connected, credible sources, journals and publications, guide documentation, and specialists/SMEs, reference them, and leverage them to the fullest extent possible.
  • Realize that regulators are accustomed to comprehending the device’s mechanism of action. Within Machine Learning, and other such innovative technologies, it is tough to detail how the device functions, so look for alternatives like Safety Assurance Cases to assist in effectively communicating risks and risk administration activities.


This fourth part of this multi-part blog series looked into some of the considerations with regards to risk and compliance. The fifth part of the blog will go into further detail about considerations with regard to risk and compliance.

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