Ira Parghi, Ropes & Gray health care counsel, discusses the increasing role that data and technology will play in a value-based health care world.
There's a lot going on when it comes to technology and health care. We started the move to electronic health records some years ago and there are incentives to providers to keep that up. We also now have what we now call "connected devices" that are connected to the internet and allow for real-time monitoring of patients on the floor. There are all sorts of things going on that really allow clinicians to get more of a real-time perspective on what's happening with their patients. So it's important because it helps with the day-to-day clinical management of patients and also because hopefully it will help providers, and payers, and others look at data from a holistic perspective and try to get an idea of the evidence on patient care – which approaches really work better and for which types of patients.
Providers, really I think as we move to value-based health care, are going to be focused on trying to understand how their existing information can be collected and used to help them meet the value-based imperative. So providers will generate what we would call "raw data" in their electronic records and otherwise – and then the challenges to pull that raw data together, and synthesize it, and turn it into some sort of information that really helps providers and others get meaningful insights about clinical care. So if you converge a hundred medical records and you look at the information from them all together, what can that information tell us about certain types of patients with certain types of conditions? Which treatments work better for them? What are their pathways like after surgery? So the challenge to providers is to work with others to figure out a way to take all of that raw data and turn it into something that's actionable.
Digital health companies of all kinds are going to play an increasing role in this space. Technology companies are going to be in this interesting business of creating software and applications to try to work with that data. A lot of that's already going on – there are some big hospital systems and academic medical centers that have started to work with outside companies to create big, meaningful data repositories that they can then work with, but we're going to see more and more of that.
Compliance programs are really going to have to look closely at what they do and what they don't do. There are already a lot of demands being placed on in-house compliance departments of all kinds. So now we're going to need compliance folks who not only know about HIPPA, and privacy, and security, and fraud, and reimbursement, but who also understand data, who can make sure that third-party providers working with the hospital to try to crunch the numbers and data are doing what they're supposed to be doing. So there's going to be a whole other level of expertise required in compliance departments.
Another part of the challenge for providers and technology companies is going to be that there are lots of different sets of laws that might come into play in this space. So HIPPA will govern records and other technologies that providers use with their patients and the payers use, but HIPPA won't govern everything. Also on the research side, there are HIPPA requirements; the FDA has its own regulations; there's something called the Common Rule, which is what applies to research funded by a large number of federal government departments. Sometimes two or three of those different regimes can come into play. Sometimes they define important concepts somewhat differently from one another. And we know that the Common Rule is about to change, so its changes will come into effect in 2018. So there's a lot going on – many moving parts and a lot of different changes or potential changes to think about, both in terms of regulation of clinical care information and the regulation of research information.
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