A question and answer chat with Robyn Shapiro from Health Sciences Law Group about her work and accomplishments in health care law.
How did you get into
My father is a doctor, and I grew up really admiring his commitment as a professional. I listened carefully as he talked about his patients, and on Sundays, I accompanied him when he went to see his patients in the hospital. I actually thought that I was going to be a doctor. I remember my mother visiting me in college and saying, “Well, you really don’t want to have a lifestyle like that, do you?” So I decided to go to law school instead. Along the
What kind of health care work do you do?
My work focuses on regulatory as opposed to transactional issues. In recent years, I’ve spent a great deal of time on
What kind of privacy issues may arise with your clients?
Privacy issues are becoming more prevalent and more complex on account of changing technology and evolving laws. Privacy issues arise in all corners of health care delivery and in research contexts. Let’s say a research study coordinator who works for an academic medical center has research-related protected health information on the laptop that she uses at work. She puts her laptop in her car one night, planning to do some work at home, stops at the grocery store on the way home, and comes out of the store to find that her car has been stolen—with the laptop in it. What actions are required under federal or state laws with respect to notifying enforcement agencies or notifying the people whose information might be involved? Then there are the things you worry about in addition to the purely legal issues, such as the reputational issues. What if the press gets a hold of this? How should your client respond to questions?
What would be the protocol in a situation like the stolen car/laptop example?
Protocol in a situation like that would depend on the facts. Who might’ve gotten access to the information? What kind of information [was compromised]? And how many people’s information might be involved? Ideally, the client’s policy would lay this all out. There likely would be an investigation to determine whether there has been a compromise of protected health information and then to determine whether there are reporting obligations, either to the government or to a state agency or to the affected individual. The policy likely would include direction for mitigating any harm and determining whether any corrective measures need to be taken. The importance of privacy issues has been enhanced with the advent of ransomware and
What can you tell me about your recent work?
I just got back from an IRB meeting. An IRB is an Institutional Review Board, charged with protecting the rights and welfare of
What are some upcoming changes in health care law?
There’s so much on the horizon. We’re all wondering what’s going to happen about health care reform and the Affordable Care Act. [There are] huge implications in so many arenas. The 21st Century Cures Act, which became law in December of 2016, makes a number of changes in various contexts. For example, it changes the approval requirements for certain medical devices, giving manufacturers a bit more leeway to get approved by the FDA. It allows some additional flexibility for drug and device companies to promote their products to certain healthcare plans, certain health care payers. In the 21st Century Cures Act, there are also certain provisions that help regenerative medicine initiatives, medicine using stem cells and research involving tissue engineering to restore normal function. Outside of that act, just in terms of technology posing new issues for health care lawyers in genetics, we’re seeing so many developments that have implications for ethics and law. For instance, now we’re able to more quickly and more efficiently edit
I saw on your website that you do work with startup companies as well?
One such client is a medical device company that is exploring the use of something called MR-guided focused ultrasounds, which, instead of surgery, creates sonication that
Are there any other activities you commit your time to?
What sort of ethical concerns are you passionate about preserving?
For me, it’s important that we properly safeguard the ethical principle of autonomy, which is the right to make out one’s own life plan. We need to keep respect for autonomy and for privacy. Another important principle that must remain in the forefront, given the ongoing health care reform debate, is justice. I hope that we will remember that, at least to some extent, we as a country have decided that health care is a right, not a