Digital Health Law Making with Bianca Phillips

VFH Episode 31

In this episode, Teri welcomes Bianca Phillips, a lawyer and leader/researcher in the area of digital health law making, and the founder of the Electronic Health Consulting Group.

Bianca is advocating for a future where telemedicine allows for access to healthcare no matter where you live, where wearables allow us to predict the onset of disease before it happens, and where clinical outcomes are improved due to precision and personalized medicine. She believes that the digital health future should balance the needs of both patients and healthcare providers by placing evidence-based approaches and civil rights considerations at the core of digital health law-making. She aims to be a prominent voice for a Digital Health School of Thought founded on these principles and will be one of the speakers at the upcoming Voice of Healthcare (VOH) Summit.

Key points from Bianca!

There at 8 pillars of digital health law making. Each is critical in the development of appropriate laws for healthcare while at the same time trying not to stifle innovation.

Bianca’s Research

She has been researching medical law and digital health law and has had support from several universities in Melbourne, Australia.
She is interested in how we can achieve a future that is immersed in digital health.
Lawmakers have the power to shape the future of digital health.
The law decides how technologies can be created, developed, and used clinically and commercially. It also imposes restrictions on the technology world in terms of what they can and cannot do.
Her interest is in how lawmakers make their choices on questions of compliance, privacy, security, data ownership, and civil rights. Her research included examining their decision making processes to unpack those choices.

The 8 pillars of digital health lawmaking

She describes them as a principle-centered framework for digital health with the idea being that principles/values that we hold dear can be at the heart of digital health decision making.

Digital Health Law Making with Bianca Phillips

Law-makers are Accountable for the Reasons of their Decisions – human rights factors, clinical benefits, societal benefits, harm reduction, risk reduction, business case, and public consultation. The idea here is that when lawmakers make statements in parliament about why they are enacting a certain law, they don’t have to provide sources, which make it difficult to ascertain the reasons for their decisions.
Human Rights – This is about applying human rights principles to lawmaking. In Australia, when a law is enacted, a statement of compatibility with human rights must be provided.
Clinical Benefit – Clinical benefits and harm reduction can be combined, and they are about applying clinical medicine principles (the idea of doing what is of benefit to a patient), applying evidence-based medicine, and also doing no harm to patients.
Societal Benefit
Harm Reduction – See Clinical benefits above.
Risk Reduction
Business Case – In Australia they have a process called the “Gateway Process”, to determine whether high risk/high cost ventures should be pursued by the government.
Public Consultation

The Issue of Data and Best Practices in the Voice-First Space

Compliance, especially in the voice of healthcare (VOH) space, is tricky. Waiting for HIPAA compliance to be met is a barrier towards VOH becoming a key contributor in healthcare.
The key focus should be in ensuring that rules that are created protect people but do not place too much of a burden on innovators. This is very tricky and jurisdiction-specific. Privacy and security is the biggest issue and it’s the aspect of digital health that gets the most attention.

Ownership and Control of Health Data

This is one of the most significant areas for assessment in the digital age.
It’s a complicated area. There have been questions about who should own and control health data.

Thought Experiment on Ownership and How it Could Apply to the Voice of Healthcare space

There is a situation where an Australia patient has undergone surgery to insert breast implants and complications arise, and the patient has to undergo a bilateral capsulotomy. A year later she develops a lump on the left side and she is diagnosed with leakage from the silicone job, and she undergoes further surgery.
The surgeon has recorded all notes using a virtual assistant (VA), and the VA took information about the description of the patient’s medical condition, the history of her referral, observations from the examination of the patient, and correspondence between the surgeon and other doctors. Those notes are very clear and easy to understand.
Sometime later, a class action litigation is commenced against the manufacturer of the implants, which is an overseas company, and they make a requirement that Australian litigants like the patient will be excluded from the settlement with the manufacturer unless the patient can file copies of their medical records in support of the claim.
The doctor would most likely not want to provide the ordered log of the conversations he had with the VA because he may be of the opinion that those conversations are personal records of his thought processes, and he might argue that they are not medical records.
So the question here is, who owns the ordered log information? The creator of the technology, the doctor, or the patient.