Back to School 2019: Rules of the road for digital health

Back to School Part 1: It's time for the biopharma industry to write rules of the road for digital health

PART 1

Rules of the Road

PART 2

Privacy, transparency and consent

PART 3

Criteria of demarcation

PART 4

Rethinking first principles

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There is a moment, just as a new technological wave starts to swell, when those creating the platform and those who will be affected by it can come together to shape its future. This moment of contingency, when possibilities can be glimpsed and irreversible decisions haven’t yet been made, is the time to write the rules of the road.

Digital health has reached that juncture.

Digital technologies will upend not only how diseases are treated, but how they are defined, reshaping the relationship between drug developers, patients and physicians.

The technology introduces a world of ethical and practical considerations that have been peripheral or non-existent for standard therapies.

Privacy, control and ownership of data will be central to digital health. Many implementations will challenge foundational properties of medicines, and not only how they are created. Machine learning will mean the drugs and diagnostics themselves will evolve continually as algorithms find new actionable discoveries down to the level of individual patient data.

Many of these issues are faced by other industrial sectors. They, too, need rules. But taking medicines is not a choice. The urgency in healthcare is far greater.

Moreover, many of the tech giants - whose reputations are far from stellar on privacy and transparency -- are moving into digital health. Biopharmas have an opportunity, and responsibility, to lead stakeholders in writing rules for digital health that everyone can accept.

Biopharmas have an opportunity, and responsibility, to lead stakeholders in writing rules for digital health that everyone can accept.

This essay builds on the concepts raised by Back to School in 2018, which asked how the healthcare world will move beyond “outcomes” to deliver comprehensive “solutions” that offer greater value for money across all stages of disease. Based on their ability to continuously monitor patients in day-to-day life, providing detailed real-time feedback on how a disease is progressing and a therapy is performing, digital technologies will be core components of this new paradigm (see “A Pathway to Biopharma 3.0”).

Digital products and tools will permeate the entire drug development continuum. They will supplement and replace today’s therapies; they will reshape clinical trials, from patient recruitment to new endpoints; they will demand new regulatory paths and standards; and they will inevitably require new reimbursement models.

Once deployed in the real world, these technologies will allow patients and their physicians to monitor the treatment journey, adjust as needed, improve adherence or change course. In some scenarios, they will allow physicians to intercept before a disease takes hold.

In this way, digital technology launches an “N of One” era of personalized therapies that use a person’s data to tailor her or his treatment path.

All companies in the healthcare ecosystem, new and old, large and small, are stakeholders in establishing the rules.

For now, digital health hovers at the edges of drug

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