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First Principles Thinking For Digital Health Lawmaking - ICT&health

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First Principles Thinking For Digital Health Lawmaking

As business philosophy advisors, we ask our clients certain fundamental questions – “what is the core value of your business?” “What else does your business stand for?” What emerges is profound.

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  • Bianca Rose Phillips, Lawyer & Philosopher

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Critical moments follow the asking of these questions that will enable the advisor to estimate with some probability whether the business has a future. If all goes well, the business will reflect on its first principles and write them down.

What follows is a deep discussion about whether those first principles authentically reflect the core business. Your job as the advisor is then to do everything that you can to ensure that the words do not rot on the paper – they are put into action, what we call holding the business accountable. Holding governments to account is another story all together.

When was the last time that we had the opportunity to look closely at the decision-making process of lawmakers and ask these types of fundamental questions – “what are the guiding first principles that you apply when deciding on whether to support a law?”

I wanted to learn about the decision-making process of lawmakers, and I used digital health as the case study. Methodology was key. I didn’t want to sit down with lawmakers and dig into their post-decision-making state, a potentially subjective reflection. Instead, the method involved an observational analysis of many years of historical lawmaking materials called ‘extrinsic materials.’ The case study selected was the Australian centralized electronic health record system (formerly called the PCEHR and now the My Health Record System). And to what end? To understand what is and what is not observable from the ‘outside.’ And to inform the industry and lawmakers of any lessons worthy of their consideration. 

There were many observations. The first discovery was that eight core pillars were observable across the lawmaking lifecycle of these systems. The existence of these pillars did not mean that they were applied consistently or applied well. It was observed that defects in the application of these pillars had a common source – the undesirable use of logical methods and reasoning techniques, which I discuss further in this article.

The first principles: eight core pillars

  1. Accountability of lawmakers. Lawmakers will provide reasons for their decisions with the use of sources.
  2. Human rights and law. Lawmakers will comply with the law.
  3. Clinical benefit. Lawmakers will respect that medical practice is grounded in evidence-based approaches and consider clinical workflow implications as well as the physician burden.
  4. Societal benefit. The societal implications of the law are considered in full, as well as the potential implications of broadening the scope of the law in the future. Societal implications are also considered when drafting the legislative purpose clause.
  5. Harm reduction. Lawmakers will consider the potential negative impacts of the law on the patient or on consumer well-being.
  6. Risk reduction. Lawmakers are aware of the risks of greatest importance to clinicians, patients, consumers, and society. They promote the consideration of these risks when designing technology and law.
  7. Business case. The business case considers jurisdiction-specific evidence and indicates any limitations of relying on overseas evidence as well as outdated sources.
  8. Public consultation. Lawmakers consult consumers and the public. There are regular updates on the number of consultations and the methodology for responding to submissions is transparent.

The eight pillars have been observed in my research of a specific area of digital health lawmaking and can be said to codify some foundational principles in digital health lawmaking. Based on observational evidence, it may be hypothesized that the eight pillars, or a variation thereof, might also be seen in the lawmaking process of jurisdictions outside of Australia. The eight pillars framework is a descriptive theory of lawmaking in the age of digital health that could also function as a normative framework.

Following the discovery of the eight pillars, I questioned the extent to which they were observable in digital health lawmaking. Any codification process needs to account for certain variables. The first is that the researcher could start to notice patterns once observed due to an unconscious cognitive bias in favor of that specific pattern. This is called the frequency illusion and it is something that a skeptic would surely raise with me. Even if the eight pillars could be challenged on the degree to which it reflects present-day practices across areas of law and jurisdictions, it could remain standing as a normative framework for digital health lawmaking.

A further point of the contest could be the abstract nature of the eight pillars. I would remind those in doubt that abstract frameworks have certain advantages that more detailed frameworks do not provide, and I encourage them to consider the value of reaching consensus on broad principles that favor the forward momentum of the digital health field. Tenets are easier to support when they are presented as general first principles. Attempts to provide the definitions and plausible constructions of these general principles lead to a contest about their meaning before any form of meaningful consensus is established.

Conclusion

For digital health businesses and advisors looking to improve the digital health field, I have a single piece of advice – consider first principles. Below you will find a questionnaire that can be used to explore the first principles of a business more deeply, or even something as complex as the machinery of the lawmaking process. This article is an adapted version of chapter 4 from my digital health philosophy book called – Making the Digital Health Revolution: Structural Elements & Logical Methods. The book, and in particular Chapter 5, takes readers on a journey that I hope will be quite profound to their understanding of the path we will need to walk prior to reaching any semblance of what is called the digital health revolution. 

Lawmaking quality review questionnaire

The lawmaking quotient (LMQ) questionnaire is a newly developed tool for reviewing decision-making processes based on the eight pillars theoretical framework described in my book. This tool is provided as a general guide because it relies on self-reporting. Thus, it does not necessarily indicate the strength or soundness of a decision, even when the LMQ score is high.

Lawmakers can ask these questions at any stage of decision-making and at all stages in the lawmaking life cycle. The central purpose of the questionnaire is to help the decision-maker turn their mind to relevant questions. The questionnaire should be used to enhance the quality of discussions that are already taking place rather than increase the administrative burden on decision-makers.

It is not my intention that the questionnaire ever becomes a mandatory component of the lawmaking process, but that it retains its nature as a voluntary guide that can be adapted and improved. Tools such as the LMQ questionnaire can serve a role when used appropriately; however, they can also frustrate a process if used in the incorrect manner and they can oversimplify complex scenarios. At this stage, the LMQ questionnaire is a tool based on the eight pillars theory and care needs to be taken to ensure that it is used appropriately. 

Exercise

  1. Find a recent article, report, speech, or staff memo that you wrote.
  2. Complete the LMQ questionnaire (see PDF below)
  3. Add up the total LMQ score and check the guide to interpreting the results.
  4. Note any lessons from completing the LMQ questionnaire.
  5. Note the areas not covered by the LMQ questionnaire that you may wish to explore further.

Instructions for using the questionnaire

Calculate the total LMQ score using the questionnaire.

For each non-bolded question in the table, insert a number from this scale. Finally, add up the total and use the guide on interpreting the LMQ questionnaire.

Note: Do not add scores for any bolded print. Bolded questions are provided for reflection and do not form part of the LMQ score. For bolded print, insert a brief answer in the table or in your notes.

Use the following scale to calculate the LMQ score:

  • 0 = not at all
  • 1 = a little bit
  • 2 = moderately
  • 3 = quite a bit
  • 4 = yes

Interpreting the LMQ questionnaire

  • Use this guide to interpret the results of the LMQ questionnaire.A score of 0-12 is a low LMQ score. This indicates that further review of decision-making is warranted.
  • A score of 13-24 is a moderate LMQ score. This indicates that further review of decision-making may be warranted.
  • A score of 25-36 is a moderate to high LMQ score and indicates that there may be some areas of improvement in decision-making.
  • A score of 37-48 indicates a high LMQ score. Improvements in decision-making may still be warranted. 

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Guest author

  • Bianca Rose Phillips, Lawyer & Philosopher

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