For AI to improve healthcare, it needs a lot of patient data from different kinds of people. AI works better when it learns from many examples. If it only sees one type of data, it may not work well for everyone and might make unfair decisions. In the U.S., doctors’ records, medical images, lab results, and other information must be shared carefully to gather enough data to build good AI tools. This sharing helps create tools that can find diseases early, suggest treatments that fit each person, and help busy healthcare workers by automating tasks.
Even though the European Health Data Space (EHDS) is a European project, it shows how sharing health data safely can help AI while keeping patient information safe. Similar ideas are important in the U.S., where laws like HIPAA protect patient privacy.
Protecting patient privacy is very important when sharing health data. The Health Insurance Portability and Accountability Act (HIPAA) sets rules in the U.S. to keep health information safe. HIPAA limits how data is shared and requires strong protection and patient permission.
Since AI needs big sets of data that might come from different hospitals or regions, healthcare managers must follow these privacy rules while supporting AI work. People are using special methods to protect privacy, such as making data anonymous or training AI without showing real data directly.
The European AI Act, starting in August 2024, is watched by U.S. regulators. It sets high rules for AI safety, clear explanations, human control, and good quality data. This law may influence how the U.S. regulates AI in healthcare.
It is important to think about fairness and ethics when using AI with health data. Studies find three main kinds of bias in AI:
In the U.S., hospitals and clinics are very different from each other. This means bias must be watched carefully to avoid unfair care. AI tools should be tested often from the time they are made to the time they are used. Teams that include doctors and patient representatives should be part of this testing to make sure the tools work well for everyone.
Because AI has ethical challenges, there are frameworks to help make sure AI works responsibly. One example is the SHIFT framework, which focuses on five main ideas for U.S. healthcare:
Using the SHIFT framework helps hospital leaders pick AI tools that match healthcare values and legal rules.
The U.S. healthcare system is very spread out. Many different hospitals, clinics, insurance companies, and information exchanges keep data separate from each other. This makes sharing data for AI harder than in some European countries where data is more centralized.
This creates problems such as:
To fix these issues, health systems are starting to use standard data formats like FHIR (Fast Healthcare Interoperability Resources). These help data sharing while keeping information secure. Groups and partnerships are also making agreements to share data ethically and safely for AI use.
One way AI can help now is by automating office and administrative tasks. For example, Simbo AI uses AI to answer phone calls and schedule appointments. This reduces the work done by staff by:
These improvements help patients and save money for clinics. AI medical scribes also help by writing down doctor and patient talks accurately. This helps doctors spend more time caring for patients.
To use these AI tools well, they must work with current EHR and office systems. They also need to follow privacy laws and fit into doctors’ normal ways of working. IT managers play a big role in choosing and keeping these AI tools safe and efficient.
Healthcare places in the U.S. are very different. Big city hospitals serve many kinds of people, and small rural clinics have fewer resources. AI must be trained on data that represent all these different settings to work well everywhere.
Fairness in AI means:
Healthcare leaders must check that AI tools have been tested for bias and performance in many kinds of patients and locations. Working together across hospitals, schools, and tech companies can help create better and fairer data and AI tools.
Because AI is now used to make decisions in healthcare, the rules about legal responsibility are changing. The European Union’s new Product Liability Directive treats AI software like a product that can cause damage with no-fault liability. This idea may influence rules elsewhere.
In the U.S., laws still mostly fall under medical malpractice and product liability. Healthcare organizations should:
Good risk management keeps patients safe and helps prevent lawsuits from AI mistakes.
To help AI grow in U.S. healthcare without losing privacy or fairness, organizations should follow these plans:
By using these steps, healthcare managers and IT leaders can support AI tools that help patients while keeping data safe and fair.
AI can change healthcare operations and medical care in the U.S. This progress depends on sharing health data safely, making AI models that avoid bias, and carefully adding AI in different healthcare places. Hospital leaders, administrators, and IT experts have an important role in guiding these changes to make care better and more available for everyone.
AI improves healthcare by enhancing resource allocation, reducing costs, automating administrative tasks, improving diagnostic accuracy, enabling personalized treatments, and accelerating drug development, leading to more effective, accessible, and economically sustainable care.
AI automates and streamlines medical scribing by accurately transcribing physician-patient interactions, reducing documentation time, minimizing errors, and allowing healthcare providers to focus more on patient care and clinical decision-making.
Challenges include securing high-quality health data, legal and regulatory barriers, technical integration with clinical workflows, ensuring safety and trustworthiness, sustainable financing, overcoming organizational resistance, and managing ethical and social concerns.
The AI Act establishes requirements for high-risk AI systems in medicine, such as risk mitigation, data quality, transparency, and human oversight, aiming to ensure safe, trustworthy, and responsible AI development and deployment across the EU.
EHDS enables secure secondary use of electronic health data for research and AI algorithm training, fostering innovation while ensuring data protection, fairness, patient control, and equitable AI applications in healthcare across the EU.
The Directive classifies software including AI as a product, applying no-fault liability on manufacturers and ensuring victims can claim compensation for harm caused by defective AI products, enhancing patient safety and legal clarity.
Examples include early detection of sepsis in ICU using predictive algorithms, AI-powered breast cancer detection in mammography surpassing human accuracy, and AI optimizing patient scheduling and workflow automation.
Initiatives like AICare@EU focus on overcoming barriers to AI deployment, alongside funding calls (EU4Health), the SHAIPED project for AI model validation using EHDS data, and international cooperation with WHO, OECD, G7, and G20 for policy alignment.
AI accelerates drug discovery by identifying targets, optimizes drug design and dosing, assists clinical trials through patient stratification and simulations, enhances manufacturing quality control, and streamlines regulatory submissions and safety monitoring.
Trust is essential for acceptance and adoption of AI; it is fostered through transparent AI systems, clear regulations (AI Act), data protection measures (GDPR, EHDS), robust safety testing, human oversight, and effective legal frameworks protecting patients and providers.