An overview of Regulatory affairs, causal inference, safe and effective health care in machine learningfor Bio-statistical services

October 6, 2020
Discuss the regulatory measures for research involving human participants
September 30, 2020
Overview of artificial neural network in medical diagnosis
October 16, 2020

Sharing is caring!


  • Over the past few years, the magnitude of machine learning in the field of healthcare delivery setting becomes plentiful and captivating.
  • Many regulatory sectors noticing these developments and the FDA has been appealing to provide bet machine learning services with safe and productive use. Despite having the limitations in software-driven products, FDA leads to giving a significant benefit of causal inference for the development of machine learning.
  • FDA is giving suggestions to provide well equipped regulated products. Pubrica is here to help you with the regulated for Bio-statistical consulting services.


The significance of machine learning has evolved globally, especially in th field of medical and healthcare sectors. Many tools are significant for various purposes likes diagnosis, software tools for many clinical findings in multiple areas. The machine learning paves an easier way to clinical Bio-statistical services using many software tools. It creates an excellent standard on radiology and cardiology and improves the patient’s medical issues rapidly, more comfortable decision making in clinical trials. All these maintained by drafting a set of regulations by various government sectors around the world.

Regulations for safe and effective health care machine learning:

FDA (food and Drug Administration)

FDA is a regulatory organization there to perform the quality of any medical or clinical testing equipment, medicines, or any food-related products. FDA is looking to provide the best facilities in health care sectors through machine-learning artificial intelligence services for the statistical programming services.  Though it is not an urgent need for ML-driven tools, there are few benefits of using ML-driven tools in medical fields, says FDA


  • Instrumental usage
  • Machine implementation
  • Invitro reagents implantation technology
  • Diagnostic kit
  • Treatment for humans and animals.

FDA definition

The usage of ML can provide both physical equipment and software tools. This software device is known as SiMD (software in a medical device). International medical device regulators verify these software-driven tools.

Challenges in SiMD

  • Cybersecurity
  • Management of data
  • Collection of data
  • Protecting information
  • To create opportunities in patient’s care


For some reasons, the FDA does not regulate two applications of ML systems. They are

  • Clinical design support software(CDS)
  • Laboratory developed tests.

The actual reason for exempting these uses are CDS provide instance decision making, which may affect in the future. On the other side Laboratory, developed tests can access only one available health care. FDA cannot regulate these type of software.

Last year FDA released a paper after conducting a serious discussion with the regulatory members and proposed “Regulatory Framework for Modifications to Artificial Intelligence/Machine Learning (AI/ML)-based Software as a Medical Device.” for statistics in clinical research. It includes some premarket research products approval procedures that would delay the ML process. Many Bio-statistical firms raised few critics against it.

The objective of the proposal is to give access to real-world data using ML products more efficiently with some regulatory barriers. It also includes some real-world affirmations. Many people could not be able to recognize this proposal. To overcome this, the FDA officials spoke to the public to create awareness about the “approach of regulating algorithms”.

Regardless of all benefits and limitations, ML is facing challenges in the development of the safe and efficient product. Some of the challenges are

  • ML identifications
  • ML predictions
  • ML recommendations
  • ML algorithms for diagnostic tools

To overcome this, Subbaswamy and Saria provide some potential remedies by discussing the statistical foundations in the Bio-statistical analysis. Data curation of individual patient’s health raises questions for request algorithms to give a more specific context.

Transfer learning

The process of learning a task from the already-completed job through knowledge transfer is called transfer learning. However, this process is complicated. The datasets can affect the algorithms, resulting in the false provisional services in health care analysis. This process is not allowed in the medical sectors.

Biomarkers in FDA

In the process of validation of a biomedical tool, biomarker validation is mandatory in the clinical research services. There are so many parameters for qualifying a biomarker. The casual inference is a novel digital biomarker validation.

An ML algorithm that detects the patient’s therapy benefits may not be relevant unless a casual inference tool access in that biomarker. Some make a precise diagnosis and treatment recommendations to understand the factors in ML algorithms. The production of digital biomarkers facing more challenges to incentivizing parties in health care sectors. R&D validated provide significance in delivery of healthcare services. Studies say that statistician’s tool kit has grown fast, and various technical tools have a development for causal inference of machine learning in biomedical investigations and reviews.


Wrapping up, in a complex environment, the role of regulatory affairs in biomedical studies for machine learning is essential. One of the easiest ways to support the regulators is the usage of biomarkers in healthcare tools. These regulations help to provide better healthcare services under the guidance of pubrica.


  1. Stern, A. D., & Price, W. N. (2020). Regulatory oversight, causal inference, and safe and effective health care machine learning. Biostatistics21(2), 363-367.
  2. Cleland-Huang, J., Czauderna, A., Gibiec, M., &Emenecker, J. (2010, May). A machine learning approach for tracing regulatory codes to product-specific requirements. In Proceedings of the 32nd ACM/IEEE International Conference on Software Engineering-Volume 1 (pp. 155-164).
  3. Hwang, T. J., Kesselheim, A. S., &Vokinger, K. N. (2019). Lifecycle Regulation of Artificial Intelligence–and Machine Learning-Based Software Devices in Medicine. Jama322(23), 2285-2286.
  4. Wiens, J., Saria, S., Sendak, M., Ghassemi, M., Liu, V. X., Doshi-Velez, F., …&Ossorio, P. N. (2019). Not harm: a roadmap for responsible machine learning for health care. Nature medicine25(9), 1337-1340.

Comments are closed.