Navigating the Legal Issues in mHealth & Telemedicine: Tricky but Not Impossible
In preparation of Health:Refactored, our code and design focused conference taking place May 13 – 14, we sat down with Scott Edelstein, Partner at Squire Sanders LLP. He’ll be covering the Legal Concerns with Telemedicine and Mobile Health and providing tips on how to navigate them. His talk will take place during the Scary Acronyms: HIPAA, USPTO, FDA, EHRs track on May 13th. Follow the Health:Refactored speaker interview series here.
Jessica: Hello, this is Jessica Goldband from Health 2.0, Program Manager at Health 2.0. I’m excited to interview Scott Edelstein today in preparation for our upcoming developers’ conference, Health:Refactored.
So, Scott, Can you tell us a little bit about your background and how you are involved in Health Refactored, the developers and designers’ conference for people in health.
Scott: Sure. I am a partner at Squire Sanders, an international law firm, and my focus is in the Health Care phase. In particular, I do a lot of work with Health IT companies. I have been doing that since the early 90’s, representing a broad spectrum of stakeholders in the Health IT space, from hospitals and health care systems, to insurance companies, to software developers, as well as electronic health record vendors. I’ve been involved for a number of years, and as part of that, I do quite a bit with respect to software licensing, liability issues related to Health IT, and also related to telemedicine.
Jessica: Can you give us an idea of who your clients are, and what their biggest pain points are as they work in health care and technology?
Scott: Well, my clients really are involved at various different levels. The hospitals that I represent are implementing new electronic health record systems, as well as numerous apps for the health care providers to enable them to more effectively provide health care to their communities. So, I get involved with advising clients on how to structure their arrangements, and towards minimizing their liability to exposure.
Part of that also entails looking at the date of privacy issues, looking at the software licensing issues, as well as looking at insurance coverage for various different types of applications that will be used in the clinical setting. I have to do work for our developers–the mobile app developers–and in that regard, I advise them on how to structure their apps to minimize exposure for those companies. Looking at issues in liability, but in particular looking at licensure issues, such as whether or not physicians are going to be providing services through the mobile app company; whether or not those physicians can do it lawfully and pursuant to state medical practice acts; looking at data privacy issues, like how to ensure that data transmissions involving patient information are protected both from a privacy standpoint, as well as from a security standpoint. Then I’m also looking at the business models, which include how well providers and others get reimbursed for all these great services and applications that are out there. So, it is a fairly diverse practice within the health IT space.
Jessica: Being that you have such a diverse portfolio of clients in this space, have you seen any trends in terms of the difficulties they are having?
Scott: Well yes, there are certainly a number of trends in the mobile apps space. There is more and more interest in developing apps that will monitor patient conditions and also provide remote treatment and diagnosis of patient conditions. The issues there are whether or not the technology can adequately provide an accurate diagnosis and treatment for the patient. More and more, we are looking at possible FDA regulation of mobile health apps, but there’s also issues regarding physician liability when physicians use the mobile health app as part of the treatment or diagnosis of the patient. And then there’s questions about data storage related to who’s handling this information, and if there any assurances that the patients’ privacy will be maintained.
I am seeing a trend: a lot of the mobile health application companies that are interested in taking patient data and using it for other purposes, such as for other marketing purposes or to sell it to third party companies have to be very carefully structured in light of the very stringent data privacy laws we have in the US.
Jessica: What do you think is the greatest value the community will get at the health law session, given that you’ll probably expand on what you just covered?
Scott: Well, I think that the important thing is to have an awareness of the various different legal obstacles that exist and how to navigate around those obstacles. I don’t think there are any legal issues that are un-navigable, but there needs to be a sensitivity to them because there is essentially a minefield of potential liability for mobile app developers if they are not aware of what those legal issues are and how to address them. A lot of these things can be addressed very early on during the development of the app, and I think that’s probably the best time to do it. Certainly, it is much more efficient from a cost standpoint to take these legal issues into consideration before launching an app.
Jessica: What would you say to someone who is weary of working in health because of the legal issues, but is still interested in creating tools to improve people’s lives?
Scott: Well, I certainly would encourage them, because as I said, the legal issues can be navigated for the most part. There shouldn’t be anything that should serve as an absolute hurdle. But, with sensitivity towards what some of the issues are, I think that there’s a lot of opportunity to develop new apps to address a lot of these market needs in health care.
The other interesting thing about the legal arena here is that there isn’t a whole lot of legal precedent. So, to some extent, these are uncharged waters that we’re navigating through. We have a pretty good sense of what types of claims could be made just based historically on lawsuits that have been filed against device manufacturers, pharmaceutical companies, healthcare companies, etc. But, for the mobile app space, it’s still so new, and there’s just been very little case law in this area.
It’s very difficult to provide any assurance, or provide any guarantee that there won’t be any liability associated with an app. But, we can certainly look at the historical precedent with how similar types of technologies have been addressed in the past, and based on that, come up with a reasonable view as to what the liability exposure would be.
Jessica: What do you think is the value of people coming to this conference and attending your session?
Scott: Well, I think the value is that they’ll get an appreciation of how to structure their companies, how to structure their business models, as well as the apps themselves to avoid legal pitfalls.
Jessica: Right. Thank you so much for your time and we look forward to having you at Health:Refactored.
Scott: Great. I’m looking forward to it.