Machine Learning
Medical device
Product Development

Understanding Data Drift in Medical Machine Learning: A Guide for AI/ML Developers

Understanding data drift types, implications, and mitigations for AI/ML devices

cosm logo
AI drift in ML Medical Devices

Understanding Data Drift in Medical Machine Learning: A Comprehensive Guide for AI/ML Developers

As the integration of machine learning (ML) in medical imaging and therapy continues to expand, AI/ML developers face new challenges, among which data drift is a critical concern. Data drift refers to changes in the data distribution between the training phase and real-world application, significantly impacting model performance. This blog post aims to introduce AI/ML developers of medical devices to the concept of data drift, the types of drift, its implications, and strategies to mitigate it.

What is Data Drift?

Data drift occurs when the statistical properties of the input data change over time in unforeseen ways. This drift can lead to a degradation in model performance because the assumptions the model made during training no longer hold true in real-world scenarios. In medical ML, data drift is particularly concerning due to the high stakes involved in clinical decisions and patient outcomes.

Types of Data Drift

Input Data Drift (Covariate Shift)

Input data drift, also known as covariate shift, refers to changes in the input data distribution. This can occur due to variations in data acquisition devices, patient demographics, or changes in clinical practices. For example, if an ML model is trained on images from a specific type of CT scanner, it may not perform well on images from a different scanner with different image quality or acquisition protocols.

Concept Drift

Concept drift is a change in the relationship between input data and the target variable. For instance, the criteria for diagnosing a condition may evolve over time, altering the labels used for training the model. A pertinent example is the reclassification of certain lung patterns from bacterial pneumonia to COVID-19 pneumonia during the pandemic.

Data Drift in the Clinical Context of Use

This type of drift involves changes in the clinical environment where the ML model is deployed. It includes alterations in clinical workflows, disease prevalence, and truth-state definitions used for evaluating model outputs. For example, a model trained with data from an urban hospital may underperform when deployed in a rural setting with different patient demographics and disease prevalence.

Implications of Data Drift

Data drift can have several negative implications on medical ML models:

  1. Performance Deterioration: Models trained on data that do not represent the deployment environment may yield inaccurate predictions, leading to misdiagnoses or inappropriate treatment recommendations.
  2. Reduced Trust:Clinicians may lose trust in ML models if they observe a discrepancy between expected and actual performance.
  3. Safety Risks: Inaccurate predictions can pose significant safety risks to patients, highlighting the need for robust ML models in clinical settings.

Mitigation Strategies

To address data drift, AI/ML developers can implement both pre-deployment and post-deployment strategies.

Pre-Deployment Strategies:

  • Data Augmentation and Domain Adaptation: Use data augmentation techniques to simulate various clinical scenarios and environments. Domain adaptation methods can help models generalize better by training on data from multiple sources or by incorporating synthetic data that mimics the deployment setting
  • Importance Weighting: Adjust the importance of training samples based on their likelihood in the deployment environment. This technique involves re-weighting cases to ensure the model pays more attention to data distributions that are underrepresented in the training set but common in real-world applications.
  • Synthetic Data Generation: Generate synthetic images for underrepresented patient demographics or image acquisition settings. This can be achieved using deep learning-based approaches or physics-based methods to create realistic training data.

Post-Deployment Strategies:

  • Monitoring and Detection: Continuously monitor the performance of deployed models using techniques like ADaptive WINdowing (ADWIN) and statistical process control (SPC). These methods can detect performance decay and signal potential data drift
  • Retraining: When data drift is detected, retrain the model with updated data to restore performance. This process should be carefully managed to avoid introducing new biases or degrading existing performance.
  • Uncertainty Estimation: Implement methods to estimate model uncertainty. Changes in uncertainty estimates can serve as indicators of data drift, prompting further investigation and potential intervention.

In fact, the FDA has published some ideas on monitoring for AI drift. You can read more about it here:

Additionally, AAMI 34971 calls out Data Drift as a risk. You can read more here about AI/ML related risks in medical devices:


Data drift poses a significant challenge for AI/ML developers in the medical field, but with the right strategies, its impact can be mitigated. Understanding the types of data drift, their implications, and how to address them is crucial for developing robust and reliable ML models for medical imaging and therapy. By implementing both pre-deployment and post-deployment strategies, developers can ensure their models maintain high performance and trustworthiness in real-world clinical settings.

Image Source: Created with assistance from ChatGPT, powered by OpenAI

Disclaimer -