Driving Healthcare Transformation Through Generative AI
and compliance . As more such GenAI-based healthcare and clinical decision support solutions will be piloted and adopted , the industry will regulate itself to improve the patient privacy and safety considerations .
Healthcare data often contains Personal Identifiable Information ( PII ) which is subject to leakage via the medical LLMs 25 . The use of synthetic data 26 , 27 is being actively explored , for training the medical LLMs , to overcome the shortage of relevant healthcare data , due to privacy and security concerns . Such synthetic data can be additionally used to create the digital twin of the hospital and patients , to augment the GenAI-based solutions .
Mayo Clinic is generating synthetic data for histopathology 28 . The privacy preserving AI is emerging as a focus area for researchers , in response to the threats posed to PII by medical LLMs 29 . Google is working on Sensitive Data Protection to help secure GenAI workloads including those in healthcare 30 .
FDA introduced regulations for software as a medical device ( SaMD ) in 2018 31 . In late 2021 , FDA introduced the AI / ML in SaMD Action Plan 32 . We will continue to see similar evolution on the digital health regulatory space . In September 2021 , the US Department of Health and Human Services introduced Trustworthy AI 33 . National Institute of Standards and Technology ( NIST ) created a Generative AI Public Work Group in June 2023 34 .
The most recent one is the Executive Order by the US President on Oct 30 , 2023 35 . The Executive Order also references the NIST ’ s AI Risk Management Framework 36 . As the Government agencies and bodies like Industry IoT Consortium ( IIC ) continue to shape this landscape , we will see increased collaboration between the health care industry and software industry to roll out GenAI based solutions benefitting the patients and different stakeholders of the industry .
25 https :// arxiv . org / abs / 2302.00539
26 https :// www . nature . com / articles / s41746-023-00927-3
27 https :// www . nature . com / articles / s41746-023-00888-7
28 https :// www . mayo . edu / research / faculty / tizhoosh-hamid-r-ph-d / bio-20530617
29 https :// www . sciencedirect . com / science / article / pii / S001048252300313X
30
https :// cloud . google . com / blog / products / identity-security / how-sensitive-data-protection-can-helpsecure-generative-ai-workloads
31 https :// www . fda . gov / medical-devices / digital-health-center-excellence / software-medical-device-samd
32
https :// www . fda . gov / medical-devices / software-medical-device-samd / artificial-intelligence-andmachine-learning-software-medical-device
33 https :// www . hhs . gov / sites / default / files / hhs-trustworthy-ai-playbook . pdf
34 https :// airc . nist . gov / generative _ ai _ wg
35
https :// www . whitehouse . gov / briefing-room / presidential-actions / 2023 / 10 / 30 / executive-order-on-thesafe-secure-and-trustworthy-development-and-use-of-artificial-intelligence /
36 https :// nvlpubs . nist . gov / nistpubs / ai / nist . ai . 100-1 . pdf Journal of Innovation 103