Healthcare AI is often created in schools or research labs but later becomes products owned by private companies. This change brings many privacy risks because private firms get access to lots of sensitive patient information. Many healthcare AI tools, like software approved by the U.S. Food and Drug Administration (FDA) to detect diabetic eye problems, need large sets of data for training. These sets contain personal health information (PHI) that must be handled carefully to follow privacy laws like HIPAA.
When private companies control AI, there are different goals. Companies want to make money from data and technology, so they want to use data as much as possible. But privacy rules limit how data can be shared and require strong safeguards to protect patient information. This conflict can weaken privacy protections and reduce how much patients control their own data.
One big concern is that many AI systems work like a “black box.” This means how the AI makes decisions is often not clear to doctors or patients. This lack of transparency makes it hard to watch over the system. Hospital leaders and IT staff may not know if AI tools handle data properly or if patient information could be wrongly used or shared.
Public-private partnerships (PPPs) are common in U.S. healthcare to help develop and use AI tools. Public health systems, hospitals, and medical schools often work with private technology companies. While these teams can speed up new ideas and cut costs, they also make it hard to decide who owns the technology and data.
A study from a Canadian university hospital showed issues that matter in the U.S. too. It found that unclear rules about who contributed what lead to fights over intellectual property (IP) and sharing value. Doctors give important knowledge for AI development but often do not get enough credit, both inside institutions and in business deals. This can make them less willing to help and hides who really owns the AI tools and data.
In U.S. healthcare, these problems are worse because of strong regulations and the high value of patient data. When patient info is shared with private partners to develop AI, questions arise about who controls the data, how it is used, and what happens if the partnership ends. Without clear IP rules, deals can fall apart and make it hard to use AI to improve care.
Also, private companies may move patient data to other places with different laws. For example, in 2016, a project between Google’s DeepMind and a British health trust faced criticism for legal issues and moving data from the UK to the U.S. This warns U.S. health providers, who must follow HIPAA and other rules.
Patient privacy is a key issue when using AI. AI needs big datasets with sensitive health info. Even when data is made anonymous, new research shows some AI can put data together and figure out who the patients are. A study found re-identification rates as high as 85.6% in anonymous activity data. This breaks old methods of protecting identity and puts health data at risk.
Many people do not trust tech companies with their health data. A 2018 survey of 4,000 American adults showed only 11% were willing to share health data with tech firms, while 72% trusted doctors more. Only 31% had moderate or full trust that tech companies could secure data.
This lack of trust affects how hospitals and clinics think about using AI, especially if private companies control the data. Patients worry that profit motives might be more important than protecting their privacy.
In the U.S., laws like HIPAA protect patient data privacy, but technology changes faster than laws do. AI systems can learn and change on their own, which means they need special rules. These include asking patients for permission often and using strong data protection.
Regulators have started working on this. For example, the FDA now approves AI software like a tool to detect diabetic eye disease made by a startup called IDx. But regulations still don’t keep up with how AI gets more complex, especially when data crosses countries or is used commercially.
Experts say new rules should focus on giving patients control. Patients should be able to understand how their data is used, say yes or no, and change their minds later. Technology should help keep track of data use and give patients clear information.
Because AI decisions can be unclear, regulators and healthcare leaders should ask for audits and explanations. This way, decisions made by AI can be checked and trusted.
One big problem with commercial AI is that patient data ownership often moves from public health systems to private companies. This can create a power imbalance that favors businesses over patients and public good.
As big tech companies control more healthcare data, there is a risk of losing control over sensitive info. Data sent across borders may be protected by different, and sometimes weaker, laws. This causes compliance problems for U.S. providers and can reduce patient trust.
Legal expert Blake Murdoch warns about private companies holding patient data without strong rules. He calls for clear oversight, contracts, and rules that explain how data should be used and protected, especially in public-private partnerships.
One possible way to protect privacy is using generative AI models. These make fake data that looks like real patient data but isn’t linked to real people. This allows AI to train without risking real patient records.
Even though synthetic data needs real data to learn patterns first, it reduces the need to share or use real patient info later. This can lower risks of re-identification and wrong data use.
Hospitals and tech partners might use these synthetic data models to protect privacy, along with asking patients for permission often and improving data anonymization.
In U.S. healthcare administration, AI is also used for tasks like answering phone calls and scheduling. Companies such as Simbo AI have built systems to handle patient calls, which helps clinics communicate better and improve access.
This automation helps administrators and IT staff by freeing them from routine tasks, lowering wait times, and making sure calls aren’t missed. But these AI systems must protect patient data during calls and follow HIPAA and other rules to avoid data leaks.
AI call platforms must have strong security, use encryption, and monitor data continuously. In public-private partnerships, clear rules must say who owns call data, who can access it, and how it is protected.
Automation also helps clinics with many calls or fewer staff. By using AI tools, managers can improve workflows, cut costs, and stay compliant.
Medical administrators, owners, and IT managers must understand how commercialization, patient data privacy, and AI use connect. They should be careful when partnering with tech companies that want access to patient data for AI.
They need to ask for clear policies about data use and make sure contracts explain who owns data, what rights are involved, and what each party must do. Admins should also support systems that give patients control over their data with technology-enabled consent management tools.
IT managers have an important job to protect data privacy. They must ensure AI follows HIPAA rules, invest in cybersecurity, and check the privacy standards of AI providers. Since the public trusts tech companies less, clinics should clearly explain to patients how their data is handled and protected.
Because healthcare AI and its rules change a lot, ongoing learning and reviewing policies is important. Administrators should work with lawyers, industry groups, and regulators to stay compliant and build patient trust.
Healthcare AI can bring many benefits but must be used with strong privacy protections, clear rules, and ethical care. As more U.S. healthcare providers use commercial AI and public-private partnerships, protecting patient data privacy must stay a priority. Only careful management can help AI serve patients without risking their rights or trust.
Healthcare AI adoption faces challenges such as patient data access, use, and control by private entities, risks of privacy breaches, and reidentification of anonymized data. These challenges complicate protecting patient information due to AI’s opacity and the large data volumes required.
Commercialization often places patient data under private company control, which introduces competing goals like monetization. Public–private partnerships can result in poor privacy protections and reduced patient agency, necessitating stronger oversight and safeguards.
The ‘black box’ problem refers to AI algorithms whose decision-making processes are opaque to humans, making it difficult for clinicians to understand or supervise healthcare AI outputs, raising ethical and regulatory concerns.
Healthcare AI’s dynamic, self-improving nature and data dependencies differ from traditional technologies, requiring tailored regulations emphasizing patient consent, data jurisdiction, and ongoing monitoring to manage risks effectively.
Advanced algorithms can reverse anonymization by linking datasets or exploiting metadata, allowing reidentification of individuals, even from supposedly de-identified health data, heightening privacy risks.
Generative models create synthetic, realistic patient data unlinked to real individuals, enabling AI training without ongoing use of actual patient data, thus reducing privacy risks though initial real data is needed to develop these models.
Low public trust in tech companies’ data security (only 31% confidence) and willingness to share data with them (11%) compared to physicians (72%) can slow AI adoption and increase scrutiny or litigation risks.
Patient data transferred between jurisdictions during AI deployments may be subject to varying legal protections, raising concerns about unauthorized use, data sovereignty, and complicating regulatory compliance.
Emphasizing patient agency through informed consent and rights to data withdrawal ensures ethical use of health data, fosters trust, and aligns AI deployment with legal and ethical frameworks safeguarding individual autonomy.
Systemic oversight of big data health research, obligatory cooperation structures ensuring data protection, legally binding contracts delineating liabilities, and adoption of advanced anonymization techniques are essential to safeguard privacy in commercial AI use.