F129 The State of Digital Health Law (Bianca Rose Phillips)
If you think like a lawyer, your brain is jam-packed during critical thinking. When Bianca Rose Phillips reads the news about digital health, her thoughts race through different areas of law.
She reads without assumptions (non-assumptive thinking), she puts facts over emotions, she thinks about challenges through the lens of a devil's advocate - looking at arguments of both sides of a problem.
Bianca Rose Phillips is a Global Digital Health Law theorist from Australia and a Digital Health Think Tank founder. In her legal work, she is focused mostly on Australia and the USA. Many people know her by her framework of the so-called 8 pillars of digital health lawmaking.
Because she was inspired by the potential of digital health, she chose to specialize in the law aspects of the field. That gives her a unique position in the legal space. Companies and lawyers would often come to her when in need of the subject-matter expertise, and she would advise them on how to approach a specific question in front of them.
8 pillars of digital health lawmaking
To make it easier for lawyers to work in digital health, Bianca designed a framework of the so-called 8 pillars of digital health lawmaking.
Eight pillars include accountability of lawmakers for the reasons for their decisions, human rights, clinical benefit, societal benefit, harm reduction, risk reduction, business case, and public consultation.
"The eight pillars framework is a suggested values framework for digital health. As people we know it's important that we understand our value system. Companies in digital health have a vision of what they want to achieve and accomplish. What I'm challenging organizations to do is to consider the values that keep digital health standing. If digital health was a house, the pillars beneath it need to be strong, and we want to keep the house standing. And you need to consider what happens when there is a conflict between two values," says Bianca Rose Phillips.
She explains this in the case of My Health Record - the national Australian backbone for patient data, in theory enabling patients and healthcare providers to have access to their medical data. "You could have a very strong argument that there is an economic benefit of the project because, with it, we will save money, which makes it an economic benefit. You may argue that there is societal benefit in doing this because the more money we have as a country and the more successful we are in business, the more we can offer our communities. But then someone else, like a medical practitioner, may very well come to you and say, what about the clinical benefit? Could you tell me what the evidence is to support this initiative? Is it actually going to improve healthcare? Could it - and this goes for another pillar - result in harm? In society, there is always tension between competing values, and there's a theoretical approach to examine this," says Bianca Rose Phillips.
Bianca Rose Phillips.
Bianca opted-out of the My Health Record System. It was a decision made based on her analysis of pros and cons for her and her family personally. As she says, this is a personal decision, and everyone needs to decide for themselves what they see most beneficial for them. She is a firm believer that patients need to be responsible for taking care of their health data. "You see this in the law. When you look at cases that go before courts in negligence, they balance how an individual has mitigated their risk. I know that's a legal perspective, but I believe that we can do a lot to empower ourselves."
Should patients own their data?
Taking care of our data doesn't necessarily mean the patient should own their data. From the legal perspective, the statement "Patients should own their data" is very complex. "The courts have been looking to understand data ownership laws for many years. There is a distinction between control and ownership. I understand where individuals saying patients should be the only ones owning their data are coming from. There is a desire for patients to be empowered. But we have to be realistic. If patients owned their data completely, what does that mean for the physicians caring for you? And what does it mean for the digital health companies who are managing that data? It's one thing to say patients need to be empowered. We want them to have more control over their lives. That's one thing. It's another thing to say patients should own all of their information, all of the data that is used to treat them."
The law can be a very effective way of bringing about societal change or changing behavior, says Bianca Rose Phillips. But sometimes the law is not the appropriate way of going about achieving change. When lawmakers chooses to act with heist they haven't prepared people and society for what's about to happen. I wear these different hats and look at these questions from different perspectives. One is the advocate and the person who loves digital health and wants to see it succeed. When I wear that hat, I think to myself, this is great. This is good because it's providing access. It could empower patients. It's shifting the paradigm straight away. But when we bring about big paradigm shifts, we need to support people so that they can manage that change, especially if it's retrospective. "
Tune in for the full discussion:
Questions addressed:
Bianca, you are a very distinctive member of the digital health community because you're a digital health advocate and a lawyer. How does your perspective on digital health look like with the legal glasses on? How does your view differ from a regular reader when your read about digital health advancements and innovations?
You created a framework of the so-called 8 pillars of digital health lawmaking. Before we dive into those, can you name a few examples of what kind of legal work you do? What do companies usually turn to you for? How much of it is litigation, and how much legal advice?
How do you weigh the 8 pillars when assessing a case? Can you describe an example? 8 pillars mean that there are 8 variables you need to take into account in decision making. That's a lot.
One of the hot topics from the legal standpoint in digital health is data sharing and privacy. While Europe is seen as a dinosaur in development because of strict data protection laws, I see it as the fortress that does remind us of serious consequences we might fall into if we're too careless about data due to convenience.
The reason I'm bringing this up is that in December last year, Google launched a program to address interoperability in healthcare, and they're now going back into creating personal health records. Additionally, Google is building Care Studio - sort of a search engine for EHRs. The idea behind Care Studio is to get hospitals to put data in a cloud service where with the help of AI, clinicians would search for relevant patient data regardless of the institution the patient was in. AI supposedly harmonizes medical data across different systems. This sounds really amazing but there's this bittersweet aftertaste here - what is going to happen if Google takes hold of medical data globally? Tomaž Gornik, the CEO of Better and the industry representative of the openEHR Foundation, said at a discussion we had on Clubhouse that Google will face challenges in gaining healthcare's trust with data. What do you think? And what's your legal standpoint?
My fear is that there's no doubt Google is creating amazing and impressive solutions. And the desire to drive digitalization forward … I fear that might triumph over privacy concerns and laws?
You come from Australia, where the national infrastructure for electronic health records gained international media attention during the implementation phase a few years ago. At the beginning, people could opt in to have their records in the backbone, and then the decision was made to create an opt-out system because that is basically a guarantee to have a higher percentage of records since most people don't want to be bothered by this and don't do anything about their records. You are among the people that opted out of the system. Why is that?
Data ownership and control is an interesting topic. In an interview for Voice First Health, you mentioned that a patient could control but not own data. I thought it was an interesting formulation because I agree that many patients don't want to own their data and be accountable if they lose it. Also, isn't it impossible from the legal perspective for patients to own and control their data because healthcare institutions need to have a copy for liability issues, right? So what does ownership even mean?
In the US On April 5, a new federal rule was enforced, which dictates healthcare providers to enable patients access to their records and notes by October 2022. turned OpenNotes' goal into the law of the land. Now, virtually every US medical practice and health system must make all information in electronic health records—with a few exceptions—easily accessible to patients at no charge. What do you think about this? The law is here but will it be enacted and to which usability extent? My Health Record in Australia is a clear example that just because something exists, it does not mean it's reaching its intended purpose. Some healthcare institutions don't put data in the record, and the eRecords stay incomplete and unreliable. Can patients do anything?