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 the mainstream use of wearables allows us to predict the onset of disease before it happens, and where clinical outcomes are improved because of uses of 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 Health (VOH) Summit.
Key points from Bianca!
- The 8 pillars of digital health law making that Bianca has come up with and how each is so critical in the development of appropriate laws for healthcare while at the same time trying not to stifle innovation.
- Bianca’s fascinating thought experiments on the voice and healthcare space.
Bianca’s Research
- She has been researching in medical law and digital health law, and has had support from several universities in Melbourne, Australia.
- She’s 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 and provide an opinion on whether they’ve been accountable for the reasons of their decisions.
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.
- They include; lawmakers should be accountable for the reasons of their decisions, human rights factors, clinical benefits, societal benefits, harm reduction, risk reduction, business case, and public consultation.
- Pillar One: Lawmakers should be accountable for the reasons of their decisions - 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 makes it difficult to ascertain the reasons for their decisions.
- Pillar Two: Human right factors - 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.
- Pillar Three and Five: 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.
- Pillar Seven: Business case - In Australia they have a process called the “Gateway Process”, to determine whether high risk/high cost ventures should be pursued by government.
The Issue of Data and Best Practices in the Voice-First Space
- Compliance especially in the voice of health (VOH) space is tricky. Waiting for HIPAA compliance to be met is a barrier towards VOH becoming a key contributor in healthcare.
- She has no doubt that meeting that compliance will happen at some point.
- The key focus should be in ensuring that the 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 VOH
- There is a situation where an Australia patient has undergone surgery to insert breast implants and complications arise, and the patient has to undergo surgery for a bilateral capsulotomy. A year later she develops a lump on the left side and she is diagnosed with a 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 examination of the patient, and correspondence between the surgeon and other doctors. Those notes are very clear and easy to understand, and in ordered log of those requests or questions that were asked to the VA are stored in the activity section of that platform.
- 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 they 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.
Links and Resources in this Episode
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