Mark Dahlby, JD, is an attorney with the law firm Hall Render Killian Heath & Lyman. His practice focuses on the development of new products and business opportunities for various healthcare industry clients, including information technology vendors, healthcare providers, pharmacies, clinical laboratories, medical device and other life sciences companies. He counsels clients on global medical device matters as diverse as regulatory approvals/clearances, clinical trials, supply chain risk management, import/export, advertising and labeling, and post-approval requirements. Previously, Dahlby worked for GE Healthcare, where he created a compliance department dedicated to global medical device regulatory enterprise risk management, and served in the United States Marine Corps.
HIMSS: How did you become involved with HIMSS?
Dahlby: My last employer, GE Healthcare, is a Diamond Member and my current employer is a very involved Platinum Member of HIMSS. In my last job, health IT was only one of many product areas of concern to my regulatory practice, so I was primarily a passive participant in HIMSS. Now, working in private practice at a law firm focused exclusively on healthcare, and health IT specifically, this area has become my primary focus. It only made sense that I start participating more actively in HIMSS, both taking advantage of all the great resources and doing my part to contribute to the conversation.
HIMSS: What has been the most rewarding aspect of your involvement with HIMSS?
Dahlby: I’m new to active involvement, so I’m looking forward to having more interaction with other members and industry thought leaders. I can say that I have been extremely pleased over the years by all of the great HIMSS publications and conferences. I’m looking forward to the mHealth Summit in December.
HIMSS: What are some of the greatest challenges of using mobile medical apps? What are some of the greatest benefits?
Dahlby: How they are developed is a challenge. Medical device manufacturers, as well as large software developers, have a host of international standards and regulations to which their products are designed and developed. In the app world, we see a lot of programs developed by folks who haven’t even heard of the International Organization for Standardization (ISO), let alone the US Food and Drug Administration’s General Principles of Software Validation. Additionally, many of these apps are designed to be used by patients and other consumers, who may not receive the same degree of training as hospital staff. Lack of training and consideration of human factors cause problems in general; in this context, problems often negatively impact patient safety. One of the greatest benefits and biggest challenges is interoperability – mobile, cloud and other home-based software products have the potential to drastically redefine medical care, and may prove to be the solution to current interoperability problems, but only if the proliferation of hundreds-of-thousands of these software programs does not cause even more interoperability problems.
HIMSS: Why is guidance from the FDA needed in the use of mobile medical apps?
Dahlby: Some people ask why FDA needs to be involved at all. The IT industry has done fine on its own for a long time without the oversight of a very hands-on regulator like the FDA. Yet, I believe there is a role for the FDA related to mobile medical apps where patient safety is an issue. The first challenge for the FDA is to define when a consumer or hospital general purpose product, like a video game, a heart rate monitor, or a prescription drug reordering program, becomes a medical device. The second challenge is defining the rules or standards that will apply to these products, so that they achieve interoperability and have some degree of consistency in the marketplace. It comes down to weighing both negative and positive impacts on patient safety, and that is basically what FDA’s recent guidance says the rules of the road will be going forward. The FDA did a good job developing this guidance – it hosted many public forums, invited all of the right people to provide input, and will be posting on its website additional examples of the health IT products it regulates and those it does not. That degree of transparency helps an industry driven by so much creativity, passion, and venture capital.
HIMSS: What advice would you give professionals just entering the healthcare or IT field?
Dahlby: Stay intellectually curious about new innovations and think about how they may disrupt existing technologies, standards of care, business revenues, law, risk management practices, patient safety, etc. I believe it is best to think about health IT’s impact on as many different subject areas as possible, because it is not standalone and static and residing by itself in a server room. Health IT is the new approach to providing patient care, which in some cases can become the standard for patient care. Understanding how each new development may fit into the larger healthcare ecosystem is vital to delivering the best results to the patients and the healthcare system as a whole.
Dahlby is a speaker for the HIMSS virtual event, “The FDA’s Mobile Medical Applications Guidance: Impact and Compliance,” which will take place on Wednesday, Oct. 23. Registration for this event is free of charge.
HIMSS: What will be the main focus of your discussion during the Oct.23 event?
Dahlby: As a panel, we will look at the regulation of mobile medical apps and related medical software, particularly focusing on the FDA’s recent guidance on mobile apps, and the risks and opportunities that come with that. Innovation in this area has been occurring at breakneck speed, and now that the FDA’s stance on the subject has been clarified, I imagine development will speed-up even more. My piece of the session will focus on the rules for developing these products, the risks to doctors and hospitals when buying and using these products (think malpractice and other lawsuits), and the steps that can be taken to mitigate some of these risks.