Key Legal Considerations at the Crossroads of Healthcare and Technology
As technology increasingly permeates every aspect of our lives, its influence on the healthcare industry is undeniable. From electronic medical records to wearable devices and AI-driven diagnostics, the healthcare landscape is undergoing a rapid transformation. This evolution, while promising, introduces complex legal challenges that healthcare organizations must address to ensure compliance with regulations and protect patient data.
Healthcare organizations must work in close collaboration with technology experts, data security specialists, and legal teams with expertise at the intersection of healthcare and technology. Legal counsel plays a vital role in assisting healthcare providers with technology contracts and usage, guaranteeing adherence to healthcare and data privacy laws and regulatory requirements. The following highlights several critical areas where specialized legal guidance is essential:
Executing Agreements with Third-Party Vendors
Healthcare providers rely on numerous third-party technology vendors to implement innovative solutions. These can range from electronic medical records and data analytics systems to vital signs wearables and medical billing platforms. Negotiating contracts with these vendors often involves navigating industry-specific jargon and addressing complicated issues related to functionality, security, data privacy, and liability. Attorneys specializing in healthcare technology can provide substantial value by guiding the following types of agreements:
- Information Technology: IT agreements encompass services like IT maintenance, system monitoring, data backup, and web development. Critical areas for legal review include project definitions, technical specifications, data access rights, cybersecurity obligations, service levels, and self-help mechanisms.
- Supply Chain: Supply chain agreements for materials, commodities, or services are vital. Given the complexity, these agreements must address key areas of planning, sourcing, production, distribution, and returns. Attention to standard “boilerplate” provisions, such as force majeure clauses, is crucial for addressing supply chain disruptions.
- Websites and Apps: The importance of having an online presence via a website or mobile application and the growing prevalence of telehealth have become crucial for healthcare providers. These platforms often utilize external parties for services, introducing legal considerations like patient privacy and data collection, sharing, and storage.
- Cloud-Based Services: Cloud-based services require careful attention to warranties, cybersecurity protections, data breach processes, limitations of liability, indemnities, and regulatory compliance in vendor agreements.
Drafting and Analyzing Terms for Websites, Apps, and Wearables
Modern healthcare providers use technology to enhance their offerings and make their services and findings more accessible. Terms and conditions and privacy statements on a healthcare provider’s website or app must clearly inform users about how their personal information is handled. Two main types of legal agreements are used:
- Terms and Conditions: Outlines visitor and user duties and rights. These agreements often address data privacy, security, and permitted activities.
- Privacy Policies: Provides users with information about data collection, storage, use, and sharing practices, and the rights they have related to their data. A detailed privacy policy is essential to building customer trust and to avoid any disputes regarding data handling practices.
Data Collection, Machine Learning, and Artificial Intelligence (AI)
With healthcare data collected and analyzed to improve patient outcomes, reduce costs, and guide decision-making, the use of machine learning and AI tools presents new challenges. Healthcare providers must ensure they understand the types of technologies used internally and externally by vendors to avoid regulatory violations, as well as address any risks in their contracts. Examples of technologies used to collect data include web scraping and AI. Healthcare providers must ensure data from their platforms used to train AI models are used in line with regulations.
Protecting and Monetizing Intellectual Property
Intellectual property (IP) is a cornerstone of technological advancements. Healthcare providers must address IP issues related to the ideas, inventions, and works of authorship of doctors, employees, and consultants. Key IP types include:
- Patents: Offered by the government to allow the building, sale, and use of an invention, such as medical devices.
- Trademarks: Words, phrases, symbols, or designs that identify a good or service. Healthcare providers use this to build brands.
- Copyrights: Legal rights to copy and authorize others to reproduce their own work for owners of an original product. This can be used for databases and software.
- Trade Secrets: Information a business makes significant efforts to keep confidential due to some value received. Within healthcare, this can cover patient lists, pricing, and contract terms.
Software in Healthcare
Software plays a critical role across the industry. From electronic health records (EHR) to billing and insurance coding, software is an integral part of administrative and clinical functions. The software may leverage medical databases of diseases, symptoms, and treatment plans to support medical research, diagnosis, and imaging. Healthcare providers face decisions regarding open-source software. Legal counsel should evaluate any development or licensing of software to ensure compliance.
The Importance of Experienced Healthcare Technology Counsel
Healthcare providers can elevate the quality of their services with technology. With each new implementation, providers must consider and address inherent regulatory regulations and liability issues. Experienced legal counsel can assist with questions, train teams, prepare compliant procedures, and skillfully negotiate agreements to mitigate risk and avoid liability.
