Healthcare is one of the most important industries in the United States. According to data from Petersen-KFF, healthcare spending continues to rise—accounting for approximately 17% of U.S. gross domestic product (GDP). Tech is changing the way that healthcare operates. The right technology can make healthcare delivery more efficient and effective while providing patients with access to better services.
Commercial opportunities await tech companies that can bring innovation to healthcare. Of course, these companies face a wide range of regulatory, legal, and business challenges in this complex industry. In this article, our healthcare tech lawyer discusses the role of legal advisors in product development for tech companies in the healthcare industry.
Healthtech Product Development is Complicated (Legal and Business Considerations)
While technology can transform health, developing products that serve the industry can be immensely challenging. The development of tech products in health care often brings together a wide array of both legal (regulatory) considerations and business considerations. Startup companies and other firms must develop a proactive, robust strategy that drives innovation in a manner that both ensures regulatory compliance and promotes commercial success.
How a Healthtech Lawyer Can Help With Product Development
A healthtech lawyer can be pivotal in dealing with the complex regulatory landscape that overrides product development in the healthcare industry. Legal advisors play a multifaceted role when working with businesses that develop healthtech products. Along with other things, a senior healthtech attorney often guidance and support with the:
- Regulatory Compliance (State, Federal, International): Healthtech products are subject to a myriad of regulations that can vary across jurisdictions. A healthtech lawyer advises regarding compliance with any applicable regulations that arise at the state, federal, and international levels. Indeed, your lawyer could offer guidance and support with everything from Food and Drug Administration (FDA) approvals for medical devices to the Health Insurance Portability and Accountability Act (HIPAA) to the European Union’s General Data Protection Regulation (GDPR) for products offered in the EU. A legal advisor can help to ensure that the product development process goes as smoothly as possible.
- Innovation Protection (Intellectual Property): Developing healthtech often takes an enormous investment. In such a hyper-competitive landscape, protecting intellectual property (IP) is a must. A healthtech lawyer assists in identifying patentable technology, filing patents, protecting trade secrets, and establishing trademark rights. IP protection is not just about securing legal rights but also about creating a strategic IP portfolio that enhances the company’s valuation and appeal to investors and partners.
- Risk Management (Mitigate Liability): The potential for liability in healthtech is significant, given the direct impact on patient health and privacy. A healthtech lawyer can play a key role in identifying potential legal risks associated with product development and usage. Your attorney can help in implementing risk management strategies, including drafting clear terms of use, privacy policies, and disclaimers. By conducting thorough legal audits and advising on product liability, data protection, and cybersecurity measures. Your lawyer can put a strong focus on mitigating the risks of litigation, regulatory penalties, and reputational damage. If you have any questions about risk management, please do not hesitate to contact our senior healthtech attorney for help.
- Business Partnerships (Contract Negotiation): Forging partnerships and negotiating contracts are fundamental to the growth and success of healthtech ventures. An attorney with experience handling healthtech product development can facilitate these processes by drafting, reviewing, and negotiating agreements with partners, suppliers, distributors, and customers. They ensure that contracts are comprehensive. A well-drafted contract can address a wide array of different business matters—from intellectual property rights to confidentiality to compliance with healthcare regulations.
The right healthtech lawyer can make the difference for your company. Our founder, president, and managing partner Robyn D. Marino, is a top-tier attorney with extensive experience in healthcare tech. With specialized expertise in technology and data issues for healthcare, insurance, and pharmacy, attorney Marino launched Global Law Link to embody collaboration and innovation.
Get Help From Our Senior Healthcare Tech Lawyer Today
At Global Link Law, we are proud to be leading advisors for healthcare tech firms. Our firm takes a unique approach that helps to bridge the gap between legalities and innovation. If you have any specific questions or concerns about healthtech product development, we are happy to help. To arrange your strictly confidential, no-commitment initial case review, please contact us today.
Sources:
https://www.healthsystemtracker.org/chart-collection/u-s-spending-healthcare-changed-time/
https://www.cdc.gov/phlp/publications/topic/hipaa.html
The information provided on this website is for general informational purposes only and should not be considered legal advice. No attorney-client relationship is created by accessing or using this website. Please consult with a qualified attorney before making any legal decisions. Global Link Law is not liable for any reliance on the information provided. Prior results do not guarantee a similar outcome.
