regulatory Archives - OF DIGITAL INTEREST

regulatory

Florida’s Extension of its COVID-19 Out-of-State Provider Waiver: A Sign of the Times

by Adam J. Rogers, Dale C. Van Demark and Danielle N. Scheer | Apr 17, 2020 | General Interest, Telehealth

Background: Issuing Florida’s Emergency Order

On March 16, 2020, Florida Surgeon General Dr. Scott Rivkees signed, stamped and finalized Emergency Order 20-002. In doing so, Florida joined what would become the vast majority of states in modifying licensure requirements for physicians in response to the Coronavirus (COVID-19) emergency.

The surgeon general’s order waived licensing requirements for out-of-state healthcare professionals, advanced life support professionals and basic life support professionals so that they could render services in Florida for the purposes of preparing for, responding to and mitigating any effect of COVID-19. In addition to waiving licensing requirements for in-person services, the order exempted out-of-state physicians, osteopathic physicians, physician assistants and advanced practice registered nurses from licensing requirements governing the provision of telehealth. The order also impacted emergency medical services training programs, physical examination requirements for physician certifications, prescription drug distribution and controlled substance prescription renewals (including medical marijuana). The order was to expire 30 days after signing—April 15, 2020.

(more…)

Telemedicine Collaborations and Partnerships: Key Considerations for Success

by Lisa Mazur | Aug 30, 2019 | Telehealth

Telemedicine collaborations, whether between technology companies and providers, health systems and patients, or other creative partnerships we have yet to see in the industry, can present numerous benefits to our healthcare delivery system and patient outcomes. However, such collaborations present a variety of regulatory, logistical and operational concerns that should be strategically addressed from the ideation stage of the collaboration onward.

Early-Stage Considerations

The strategy behind the collaboration should be developed with an eye towards the duration of the relationship and the development of mutually beneficial goals and objectives that are clear and measurable. Each party should be transparent about their capabilities and strategic vision at the outset of the collaboration talks to avoid any surprises or disappointments deeper in the future. Questions for potential collaboration partners include:

Is this an experimental partnership or a long-term plan?
What do I bring to the table? How can this partner supplement or support my capabilities?
How will this relationship be branded and marketed? Do I need greater visibility than my partner, or will we come together under a new brand?
Do we have the IT infrastructure and vendor relationships in place to execute this collaboration? If not, how will secure what we need?
Do we have the resources to meet the regulatory requirements of the partnership?
How will we measure the success or failure of the collaboration?

Considerations in the RFP Stage

After the initial strategy discussions have taken place, the proposal period raises its own series of considerations. After ensuring that the arrangement proposed can address the goals and objectives of the collaboration, regulatory and transactional issues take center stage. Rights and responsibilities of each party, reporting and compliance mechanisms, fees, credentialing, licensing and privacy compliance and liability issues, to name a few concerns, are addressed at this point in the process. Fees structures and compliance with the evolving federal and state laws regulating telemedicine providers are particularly complex issues that should be addressed at this point.

Questions to address regarding fees include:

(more…)

Three Tips for Tackling Risk in Digital Health

by Dale C. Van Demark and Lisa Mazur | Jul 12, 2019 | Big Data

Digital health companies face a complicated regulatory landscape. While the opportunities for innovation and dynamic partnerships are abundant, so are the potential compliance pitfalls. In 2018 and in 2019, several digital health companies faced intense scrutiny—not only from regulatory agencies, but in some cases from their own investors. While the regulatory framework for digital technology in health care and life sciences will continue to evolve, digital health enterprises can take key steps now to mitigate risk, ensure compliance and position themselves for success.

Be accurate about quality.

Ensuring that you have a high-quality product or service is only the first step; you should also be exactingly accurate in the way that you speak about your product’s quality or efficacy. Even if a product or service does not require US Food and Drug Administration clearance for making claims, you still may face substantial regulatory risk and liability if the product does not perform at the level described. As demonstrated in several recent public cases, an inaccurate statement of quality or efficacy can draw state and federal regulatory scrutiny, and carries consequences for selling your product in the marketplace and securing reimbursement.

Tech companies and non-traditional health industry players should take careful stock of the health sector’s unique requirements and liabilities in this area, as the risk is much higher in this arena than in other industries.

(more…)

Digital Health in the UK: The New Regulatory Environment Under the Medical Device Regulation

by Gary Howes and Sharon Lamb | Jul 3, 2019 | Data Privacy

Investment in artificial intelligence (AI) and digital health technologies has increased exponentially over the last few years. In the United Kingdom, the excitement and interest in this space has been supported by NHS policies, including proposals in the NHS Long Term Plan, which set out ambitious aims for the acceleration and adoption of digital health and AI, particularly in primary care, outpatients and wearable devices.

Although these developments are encouraging to developers, there is still no clear framework for reimbursement or tariffs for digital health tools and AI.

At the same time, the plethora of new technologies has led to increased calls for regulation and oversight, particularly around data quality and evaluation. Many of these concerns may be addressed by the new Medical Device Regulation (MDR) and other regulatory developments. In fact, there is some risk that while regulatory landscape is moving quickly, the pricing environment is still a way behind.

In May 2020, the new MDR will change the law and process of certification for medical software. The new law includes significant changes for digital health technologies which are medical devices. In March 2019, the National Institute for Health and Care Excellence (NICE) also published a new evidence standards framework for digital health technologies. The Care Quality Commission (CQC) already regulates online provision of health care, and there are calls for wider and greater regulation. The government has also published a code on the use of data in AI.

Digital Health Technologies and the MDR

The new MDR will mean a significant change to the regulatory framework for medical devices in the European Union.

As with the previous law, the MDR regulates devices through a classification system.

The new regime introduces new rules for medical software that falls within the definition of device. This will mean significant changes for companies that develop or offer medical software solutions, especially if their current certification has been “up-classed” under the MDR.

Key Takeaways for Investors in Digital Health Tools

Companies and investors in digital health should:
(more…)

Breaking into Digital Health: Factors Companies Must Consider

by McDermott Will & Emery | Sep 13, 2018 | Big Data, Uncategorized

Companies looking to enter the digital health field face myriad legal implications unique to doing business in this sector. Whether emerging or established, companies exploring health care opportunities benefit from careful planning around complex issues such as pace of development, reimbursement systems, strategies for responsible data collection and use, and effective corporate compliance programs. In this podcast, McDermott partners Sarah Hogan, Lisa Schmitz Mazur and Dale Van Demark take a closer look at these and other important factors companies should review when contemplating a move into the digital health ecosystem.

Q. What issues should companies consider before they enter today’s digital health care market?

DV: The first and perhaps most important thing to focus on is the business plan. A lot of business plans that may work in other service sectors may not work in the health care industry because of the way that it is structured or because of consumer expectations.

Beyond that, there are real cultural differences that we see technology companies come up against when they enter into the health care market. Frequently, technology companies are used to a very fast pace. They are used to making mistakes and learning from them, and evolving and developing to move forward. The health care industry has traditionally been much slower and more deliberative, with the goal of getting it right the first time being predominant. That cultural difference can cause problems in building relationships and setting expectations for both pace and service levels.

Finally, understanding the complexity of health care infrastructure is very important. Understanding how the health care system works and how your product, service and business plan work within that ecosystem is critical to establishing the relationships you want and really selling into that marketplace. (more…)

Maximizing the Value of Big Data in Digital Health

by McDermott Will & Emery | Aug 16, 2018 | Big Data, Data Privacy

The interest in leveraging the value of big data in digital health has become a focus of health care industry mainstays and newcomers alike. Within a challenging regulatory landscape, it is critical for those looking to play in this space to be proactive in planning their data strategy, with an eye towards compliance planning and solid due diligence to maximize its value. In this Q&A, big data thought leaders Bernadette Broccolo and Sarah Hogan, both partners in McDermott Will & Emery’s Health Industry Advisory group, discuss the challenges and opportunities that health industry stakeholders face when stepping into the world of big data.

For information on this topic and to hear the full Q&A with Bernadette and Sarah, listen to the newest episode of the Of Digital Interest podcast. You can access the full episode at here or subscribe to the podcast on iTunes, Pocket Casts or Soundcloud.

Q. Where is the value in big data in digital health? Who is seeing value today and what are their motivations?

BB: The best short answer is that everybody is seeing value – both long standing industry players and newcomers. The real value in big data comes not from raw data or just having a lot of data, but in the ability to use it and mine it, to have it in a form that’s analyzable. What’s very surprising too, in addition to the speed with which the interest in big data has escalated, is who is interested. In the past, one certainly expected academic medical centers and universities that have major research initiatives and clinical trial initiatives to be interested. But now others like molecular lab testing organizations, CLIA regulated laboratories and entrepreneurs are interested in capturing data.

SH: I think one of the surprising players is actually the pharma companies. It may sound odd to say that, but they have a lot of data – including a lot of clinical data – that they’re looking at mining to determine how they can target their therapeutics in a way that helps patients more efficiently. They are looking at themselves and asking “What does the 21st century pharma company look like?” (more…)