Artificial intelligence (AI) is rapidly transforming the healthcare landscape, offering powerful tools for diagnosis, treatment, and patient care. As highlighted in previous discussions within this ongoing series on healthcare innovations, the potential of AI in this sector is immense. Many of these advancements rely on machine learning, a sophisticated technology that enables systems to learn and improve from data without explicit programming for every task. This means AI algorithms in healthcare are trained on vast datasets of medical information, and their effectiveness is directly proportional to the quality and quantity of this training data.
However, accessing and utilizing these large datasets raises critical questions, particularly concerning data rights. For developers seeking to commercialize healthcare AI tools, securing adequate data rights is not just a legal formality—it’s a fundamental prerequisite for success. This article, continuing our exploration into the strategic aspects of AI in healthcare, delves into the essential contractual commitments that developers must obtain to ensure they possess the necessary data rights for both the development and commercialization phases of their AI-driven healthcare solutions.
At every stage of data acquisition, whether you are partnering with a strategic collaborator, engaging with a customer, or sourcing data from a third-party aggregator, there are three crucial steps to take. First, it is paramount to secure explicit rights to utilize the data for commercial applications. Second, you must obtain contractual assurances from the data provider affirming their legitimate right to furnish the data for your intended purposes. Finally, it is essential to require the data source to deliver the data in a format that is appropriately labeled and structured, enabling your algorithms to effectively learn and discern relationships between data features and their corresponding labels.
Data Rights at the Development Stage of Healthcare AI
Initially, the algorithm driving your healthcare AI tool may originate from a collaborative endeavor with a specific health services system. In such partnerships, you might be granted access to the health system’s data, specifically for developing tools aimed at enhancing care for their patient population. However, to transition from this developmental phase to commercialization, it’s imperative to solidify explicit rights within your written agreement with the health system. This agreement must authorize the use of the data set to benefit broader populations and for your company’s commercial objectives.
Often, a health system will stipulate, as a condition for granting such data usage rights, that you rigorously protect patient privacy through data de-identification. Contracts governing the sharing of health data for commercial purposes frequently detail the specific methods for de-identifying data to ensure it no longer qualifies as “personal health information” (PHI) as defined and regulated under HIPAA (refer to our earlier discussion on HIPAA considerations relevant to AI in healthcare). Proactively defining and understanding the de-identification process before approaching any data source is highly advisable. This demonstrates your commitment to responsible data handling and builds confidence in you as a trustworthy business partner.
Securing Data Rights from Healthcare Customers
For a healthcare AI tool to achieve maximum utility and effectiveness across a diverse customer base, it’s crucial that each customer consents to contribute the data processed by the AI tool back into its overall dataset. This data feedback loop is vital for continuous improvement and broader applicability of the AI. To legally establish this, your customer agreements must incorporate specific contractual clauses. These clauses should clearly state that your company retains a perpetual, irrevocable right to use the data provided by the customer and processed by the AI product.
Similar to data obtained during development, customers will understandably mandate that their data be de-identified before it’s used for purposes extending beyond serving their own patient population. This ensures compliance with privacy regulations and maintains patient confidentiality while still allowing for the aggregated data to enhance the AI tool’s capabilities for all users.
Obtaining Data Rights from Commercial Healthcare Data Sources
A significant challenge in the healthcare data landscape is its fragmented nature. Vast amounts of healthcare data are often locked within the isolated and un-integrated data systems of various health service providers. Consequently, data acquired solely from development partners and direct customers might be insufficient for your product’s needs. In such cases, licensing de-identified data from commercial data aggregators becomes a necessary strategy. These aggregators specialize in compiling data from numerous healthcare providers and related entities.
Unlike data sourced directly from customers, where you and the customer can collaboratively manage data labeling, organization, ingestion, and de-identification processes, acquiring data from aggregators requires a different approach. You must meticulously stipulate, through contracts with the aggregator, the precise characteristics and quality benchmarks of the data you are purchasing. Furthermore, it is crucial to ensure, and ideally have the aggregator legally warrant, that the data provided has been de-identified in full compliance with HIPAA regulations. This warranty provides a layer of legal protection and assurance regarding data privacy compliance.
In conclusion, securing comprehensive data rights from the outset of product development and throughout your product’s lifecycle is not merely a legal consideration; it is an indispensable element for achieving commercial success in the competitive field of healthcare AI. By proactively addressing these contractual and legal aspects of data acquisition, developers can lay a solid foundation for innovation and market leadership.
[View source.]
