Telemedicine’s growth in 2025: Key regulatory shifts and legal implications

As we look toward the future of healthcare, telemedicine continues to evolve as a cornerstone of patient care. The landscape for telemedicine is being shaped by new regulatory frameworks, legal challenges, and the growing demand for flexible treatment options. This shift presents a dynamic intersection of policy, technology, and healthcare delivery.

From drug manufacturing lawsuits to the expansion of telemedicine prescriptions for opioid use disorder, these developments are poised to reshape the delivery of healthcare in the coming years. This article will explore the changes in telemedicine regulations, the legal battles surrounding drug compounding, and how these elements intersect to create a new healthcare ecosystem.

Changes in telemedicine regulations

Telemedicine has experienced rapid growth, especially during the COVID-19 pandemic, when in-person visits became more challenging. The U.S. government has responded by introducing regulatory changes that aim to expand access to healthcare while maintaining safety protocols. This year, several changes to telemedicine regulations are expected to shape the delivery of care, especially in the prescription of controlled substances.

However, new regulations now allow qualified practitioners to prescribe medications like buprenorphine for OUD through audio-only telemedicine encounters, a move that can significantly improve access to care, particularly in underserved regions. This change comes with the requirement that practitioners review the patient’s PDMP data to ensure safe prescribing practices.

These regulations are part of a broader shift to integrate telemedicine into more routine healthcare practices, offering patients a more accessible and convenient way to manage their health. Whether through audio-only or video consultations, these changes provide an alternative to in-person appointments for the treatment of conditions like OUD, chronic diseases, and even weight management.

Pharmaceutical industry legal challenges

While telemedicine regulations are evolving, so too are legal challenges in the pharmaceutical industry, especially when it comes to drug compounding and the unauthorized prescription of medications. In a significant move, drug manufacturer Eli Lilly has filed a lawsuit against four companies involved in making, prescribing, and selling compounded versions of its weight loss and diabetes drugs, ZEPBOUND® and MOUNJARO®.

Eli Lilly’s lawsuit claims that companies like Mochi Health and Fella Health are illegally providing compounded versions of its FDA-approved tirzepatide drugs for diabetes and obesity treatment, potentially risking patient safety.

The lawsuit centers on violations of California’s Corporate Practice of Medicine laws, which prevent unlicensed individuals from controlling medical practices, including prescribing medications. Eli Lilly argues that the non-licensed founders and CEOs of these companies are making medical decisions, raising concerns about patient care and the lack of professional oversight in drug compounding.

This case underscores the increasing scrutiny of pharmaceutical companies involved in medical practices without proper licensing, highlighting issues of false advertising, unfair competition, and public health safety.

Buprenorphine treatment and telemedicine

The expansion of buprenorphine treatment via telemedicine marks a significant shift in healthcare. Buprenorphine, a key medication for opioid use disorder (OUD), has been limited by the need for in-person evaluations, especially in rural areas or for those with limited access to healthcare.

Recent regulatory changes now allow practitioners to prescribe buprenorphine through telemedicine, including audio-only consultations. This approach enhances treatment accessibility, as practitioners must review the patient’s Prescription Drug Monitoring Program (PDMP) data to ensure safe prescribing. It also allows for the prescription of an initial six-month supply, offering greater flexibility in treatment.

While these changes improve access, it’s crucial to maintain oversight to ensure safe and accurate prescriptions. With telemedicine becoming more common, rigorous monitoring is essential to prevent misuse and protect patient safety.

Telemedicine, compounding, and oversight

Telemedicine’s expansion raises concerns about drug compounding and corporate practices, highlighting the need for stronger oversight. Eli Lilly’s lawsuit underscores the risks of unlicensed medical practices, particularly in telemedicine, where monitoring can be challenging. Both compounded medications and opioid prescriptions via telemedicine require increased regulation to ensure safety.

Prescribing controlled substances like buprenorphine through telemedicine must be closely monitored to prevent misuse. As telemedicine grows, regulatory bodies like the DEA and HHS must ensure ethical prescribing and patient safety while addressing issues around drug compounding and corporate influence in medical practices.

The evolving regulatory landscape reflects the growing complexity of healthcare, where traditional in-person visits and telemedicine must coexist. Finding a balance between accessibility, safety, and oversight will be crucial in navigating future healthcare challenges.

Future of telemedicine and regulations

Telemedicine, drug compounding, and pharmaceutical regulation in 2025 are shaping healthcare’s future. As telemedicine grows, it improves access to care, especially for underserved populations. However, ensuring safety and quality, particularly with controlled substances like buprenorphine and compounded drugs, remains a challenge.

The ongoing legal battles, such as Eli Lilly’s lawsuit, highlight the need for strong corporate oversight and regulations to protect patients. Meanwhile, expanding buprenorphine treatment via telemedicine offers hope for individuals with opioid use disorder, providing continuity of care without in-person visits.

As telemedicine evolves, collaboration between healthcare providers, pharmaceutical companies, and regulators is essential. With proper safeguards, telemedicine can become a vital tool in modern healthcare delivery.

Importance of safeguards and regulatory oversight

In light of the expanding role of telemedicine, it’s crucial that safeguards are put in place to ensure patient safety. This includes verifying patient identities, conducting thorough reviews of medical histories, and ensuring that practitioners adhere to the highest standards of care when prescribing medications. These steps will be necessary to balance the benefits of increased access with the need to protect patients from potential harm.

As the regulatory landscape for telemedicine and drug compounding continues to evolve, both healthcare providers and pharmaceutical companies need to stay informed and adaptable. The combination of telemedicine and online prescriptions offers significant benefits, but it requires continual oversight to ensure that it doesn’t inadvertently lead to misuse or substandard care.

Navigating the changing healthcare terrain

The future of telemedicine in healthcare hinges on balancing accessibility, safety, and regulatory oversight. The regulatory changes in 2025, including those related to buprenorphine treatment and the growing scrutiny of drug compounding practices, underscore the need for ongoing vigilance.

As the healthcare industry adapts to new technologies and practices, it will be essential to continue refining the rules that govern these innovations to ensure that patient care remains the top priority. The year 2025 marks a transformative moment in healthcare, one that will require careful consideration and adaptation to the changing landscape.