Health 2.0 Law: What Is and Isn’t in Writing


The law book is only symbolic. The truth is, there isn’t a health information technology law manual. Many health tech companies are trying things that have never been done before and, therefore, will run into legal issues the field hasn’t seen before. That said, members of the law panel at Health 2.0 Spring Fling explained what they do know about HIT law based on their experiences as well as what is currently in writing. Here’s a few of their key take aways.

Karie Rego, Sheppard Mullin
On practicing medicine across state lines

Rego talked about her daughter who has a rare disease called kawasaki’s. She said there are only two doctors in the country who treat this disease regularly ― one in San Diego, CA, in the state where Rego lives, and one in Boston, MA. When her daughter was being treated for her disease, Rego often talked on the phone with the Boston doctor. Practicing telemedicine across state lines can raise some issues.

“The first thing whenever I work with a company is deciding is there a chance that what we’re doing here is medical care? And if it is, then where does it fall into that state rubric? And oftentimes that involves taking a look at different states where you’re operating.

It might, in some cases, involve limiting your business plan to certain types of states, at least initially, so you can get a handle on it. So you’re not running into problems with respect to the practice of medicine in different states. The boards of medicine can be extremely aggressive.”

Brian French, Nixon Peabody LLP
On documentation

French was prompted by a question from an audience member who asked if there’s a standard way to document company actions. French said no, but offered this:

“The more you can do up front to show why you’re doing what you’re doing, the better off you’re going to be. So when you come up with any kind of contracts, being able to establish ahead of time here’s the need, here’s the medical need, here’s the patient need for what we’re trying to accomplish and why. And here’s why our strategy makes sense. The more you have up front and can point the government to afterwards, it’s a huge benefit to have.”

David Harlow, The Harlow Group LLC
On FDA regulation

The FDA is in charge of regulating electronic medical records and will likely start regulating many more health applications.

“They have asserted that the definition of device in their old statute includes virtually anything you can think of, and that includes electronic health records. Any time a health record moves from just a repository of information to anything that is approaching medical decision support, that is now a device, and that is something that is going to be subject to FDA regulation.

Last year, as you know, the FDA put out a draft policy on mobile health. And they basically said in that draft guidance, they’re looking at mobile platforms, mobile apps, mobile medical apps. And they define a mobile medical app as simply something that meets the definition of a device under the law. And for purposes of this guidance, they are looking at mobile medical apps as something that’s used as an accessory to a regulated medical device or that transforms a mobile platform into a regulated medical device.”

Jack Eiferman, Goulston & Storrs
On the misnomer of a kickback

“It’s a bad term because the term Kickback, I think, is a suggestion that you’re engaging in some kind of venal behavior. That’s not what’s going on. That’s not what the word tries to capture.”

“They want the decision making by health care providers to be pristine, to be uninfluenced by any of the considerations in the commercial marketplace. It’s modeled on the single family physician making decisions and having those decisions remain unsullied.”

Dan Orenstein, athenahealth
On his top tips and tactics

·Encrypt your data
·De-identify information
·Encrypt your transmissions
·Use a standard business associate agreement

For more on health 2.0 law, check out Harlow’s blog post on SeachHealthIT.com.

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