rules + policy

motivation

When thinking about rules in the context of health, the most common defaults are to the Food and Drug Administration (FDA) as the regulator of pharmaceuticals and medical devices, and to the Centers for Medicare & Medicaid Services (CMS) which provides healthcare insurance coverage to 100 million Americans. This makes sense as the rules of FDA and CMS combine to largely determine which healthcare products are marketable and how much they will be sold for.

The general idea of a “rule,” though, can be read to encompass a wide-range of things including statutes, regulations, common law, guidelines, contracts, norms, corporate policies, and unspoken practices. At the intersection of health and technology, each of these rule categories applies, and each has tangible effect on health outcomes.

Digitalis Research is particularly interested in how rules create the context for innovation, finance, and justice in health and technology. For example, basic science research has become the subject of an increasingly open confrontation between those that view scientific knowledge as a common good to be shared and those that see it as a commodity to be exploited for private economic gain.

Scientists traditionally strive to be the first person to make an important discovery and communicate this advance in knowledge to the broader community.  The customary rewards for being first to discover include high-profile publications, important prizes, and more and easier grant funding.   This framework for science is seen to drive the rapid and open communication and use of new knowledge.

Since the passage of the Bayh-Dole Act in 1980 (a rule in the form of a statute), scientists who arrive at new knowledge first have, in addition to the customary rewards, an additional perk—the opportunity for their universities to own patents on their discoveries.  The ownership of patents allows institutions (and individual scientists) to exploit their findings for their institutional (and personal) economic benefit.  This private benefit, though, slows the communication and may limit the use of that new knowledge.  This framework for science allows the privatization of knowledge for the economic benefit of the discoverer.

Should there be profit in knowledge and how should our rules guide the balance between motivating private investment and supporting the public good?