Enhancing Patient Safety in Digital Therapeutics: AI- Driven Approaches

Enhancing patient safety in digital therapeutics through AI-driven approaches involves leveraging artificial intelligence to ensure the effectiveness, accuracy, and security of digital health solutions. Here are some key strategies and benefits

1. Welcome The intersection of safety and Digital therapeutics :An AI perspective 10/06/2024 www.clinosol.com | follow us on social media @clinosolresearch 1 Mahaboob Begum Pharm. D 059/052024

2. Index Introduction to artificial Intelligence (AI). What is Digital therapeutics ( DTx ) and how it works? What is patient safety ? Intersections of  patient safety and digital therapeutics with AI.  Conclusion 10/06/2024 www.clinosol.com | follow us on social media @clinosolresearch 2

3. Introduction to artificial Intelligence (AI) 3 Artificial Intelligence : Artificial intelligence (AI) is the simulation of human intelligence processes by machines or computer systems. Natural language processing, speech recognition, expert systems, or machine vision are common applications of AI. AI encompasses machine learning and natural language processing. To identify latent information or make predictions about the data without explicit programming. And have societal impacts in the health care domain and are also frequently used in the health care field . 10/06/2024 www.clinosol.com | follow us on social media @clinosolresearch

4. What is Digital therapeutics( DTx )and how it works? ​ Digital therapeutics ( DTx ) is a concept of delivering  evidence-based care and clinically validated therapeutic interventions for patients, driven by advanced technology and high-quality software programs to prevent, manage, or treat a medical disorder or disease. Digital therapeutics coupled with artificial intelligence and machine learning systems to monitor and predict individual patient symptom data in an adaptive clinical feedback -loop via digital biomarkers to provide a precision medicine approach to healthcare . Includes A devices for sensing the patient’s metabolic or systemic vitals (HbA1c, blood urea nitrogen, essential minerals, heart rate, O2 saturation, ECG, etc.). 4 10/06/2024 www.clinosol.com | follow us on social media @clinosolresearch 4

5. An edge device (e.g., smartphone) to communicate with the database and display alerts or recommendations. A database to store the sensed parameters and (AI)-enabled software Need of DTxAI  : With growing population there are simply not enough medical professionals to take care of all the patients all the time, & these patients can benefit from ongoing personal  support to manage their conditions and stay healthy. This differs from traditional therapeutic approaches, where a treatment regimen is designed for patients and then evaluated and modified only at periodic intervals (if ever), often months after the initial prescription. Traditional medications do not provide a closed-loop feedback mechanism that will adapt itself or change its dosage as the body reacts to surrounding environmental factors or the intervention itself. 5 10/06/2024 www.clinosol.com | follow us on social media @clinosolresearch

6. What is patient safety and intersection of safety with respect to artificial intelligence 6 Patient safety is defined as the absence of preventable harm to a patient and minimization of the risk of harm associated with the health care process Potential Patient safety with AI : via “Clinical” and “Diagnostic” level interventions and decision support system(DSS) . Help in enhancing patient safety by improving error detection, patient stratification, and drug management. To predict drug interactions by analyzing  (Electronic health record) EHR  data , unstructured discharge note ,and clinical charts. to identify drugs that were withdrawn from the commercial markets by the FDA. 10/06/2024 www.clinosol.com | follow us on social media @clinosolresearch

7. From Rx to DTx AI in health care 7 10/06/2024 www.clinosol.com | follow us on social media @clinosolresearch

8. Intersections of  patient safety and digital therapeutics with AI 10/06/2024 www.clinosol.com | follow us on social media @clinosolresearch 8

9. Applications of digital therapeutics with AI    Cardiology :- Its applications in imaging, electrophysiology, and heart failure prediction, as well as preventive and interventional cardiology. AI models can be used for an electrocardiogram (ECG) analysis. Allergic diseases:- Helps in diagnosis of allergic diseases by Analyzing patient data, such as medical history, allergy testing results, and environmental exposure data, to identify patterns and associations that may be indicative of allergic diseases. Asthma & COPD :- AI software combined with hardware program to improve Asthma and COPD control and optimize healthcare utilization enable asthmatic patients to achieve better results, thanks to intelligent inhalers( e.g ACT4Y Asthma control for you) and the use of data to customize and ‘calibrate’ the use of drugs 9 10/06/2024 www.clinosol.com | follow us on social media @clinosolresearch

10.   AI Implications in Immunology and COVID-19 Served as an effective option for fighting the COVID-19 outbreak by eliminating direct contact with other people in the health care setting. New system to analyze CT Scan data of patients using deep learning and concluded that the right lower lobe of the lungs is the most common location for COVID-19 pneumonia. IN DIABETES :- A glucose measurements in the interstitial fluid (i.e., a digital biomarker)continuously react to the body as an adaptable “artificial pancreas” providing interactive glycemic control and insulin delivery. correlate to blood glucose levels and carbohydrate intake,& based on these measurements, precise insulin dosing is automatically delivered by a wearable insulin pump. This allows the patient to stay in a more tightly controlled glycemic window without the potential detriments of prolonged periods of hyper- or hypoglycemia. 10 10/06/2024 www.clinosol.com | follow us on social media @clinosolresearch

11. Dementia &   Alzheimer's Disease(AD)  :- Non-invasive Monitoring and Progression Analysis    done analyze images of the subject's head or facial features to detect signs of cognitive decline. Offers early diagnosis, personalized treatment plans, and continuous monitoring of patients with AD, MCI, and dementia  Attention-Deficit/Hyperactivity Disorder (ADHD ) T he integration of ML for diagnosing ADHD addresses a critical need for more accessible and precise diagnostic tools. By evaluating clinical parameters and refining the model's accuracy with data from previously diagnosed patients, this system improves the diagnostic process. CANCER :- Enhancing Treatment Precision and Safety for cancer patients, addressing both the psychological and physiological aspects of oncological care & focusing on immune checkpoint inhibitor (ICI) therapies and radiotherapy. By predicting immune-related adverse events ( irAEs ) ,enhancing the Objective Response Rate (ORR), which allows early detection and intervention. The analysis of electronic patient-reported outcomes (ePROs) provides crucial insights into treatment-induced symptoms and toxicities . 11 10/06/2024 www.clinosol.com | follow us on social media @clinosolresearch

12. Conclusion Digital therapeutics with AI (DTx.AI) allows more convenient and effective monitoring & treatment of patient symptoms and provide more time for physicians to spend with their patients for emotional, empathetic & personal matters AI can adapt in real-time to the patient's current and predicted health state in a way that no traditional therapeutics can achieve. Also incorporate hundreds of complex personal variables for each patient to provide more customized algorithms and interventions, which may be impossible for a human to evaluate. Help  to detect  adverse events and drug interactions and contribute to drug safety monitoring . 12 10/06/2024 www.clinosol.com | follow us on social media @clinosolresearch

13. Reference Exploring the Intersection of Artificial Intelligence and Clinical Healthcare: A Multidisciplinary Review - PMC (nih.gov) Role of Artificial Intelligence in Patient Safety Outcomes: Systematic Literature Review - PMC (nih.gov) The Need for Artificial Intelligence in Digital Therapeutics - PMC (nih.gov) Will AI and Generative AI driven Digital Therapeutics be the keystone in the grand arch for Pharma, as it gears up for more drugs getting off-patent and off-exclusivity? | GAVS Technologies. 13 10/06/2024 www.clinosol.com | follow us on social media @clinosolresearch

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