One of the most reliably interesting voices on Linked In is Joe Lennerz, successively of Harvard, Boston Gene, and now Natera. Find his home page here, his Linked In postings here.
In the last few days he's co-authored several important publications. Kahles et al. appears in Health Policy & Technology, covers major problems arising from recent changes to IVR regulations in Europe. Find it here.
Pair that with Schneider et al., Npj Digital Medicine, wit the title, "Can Laws Be Flexible? Rethinking Legislation for Innovation." Released July 22, find it here.
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AI Corner
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Two 2026 Papers on Making Diagnostics Regulation More Adaptable
Schneider et al., “Can Laws Be Flexible? Rethinking Legislation for Innovation.” This broad conceptual paper asks how legislation can remain stable and democratically legitimate while responding more intelligently to rapid technological change. The authors borrow the idea of “agility” from software development—not to advocate quick-and-loose lawmaking, but to build feedback, evidence collection, periodic review, and predefined opportunities for revision into the regulatory lifecycle. They distinguish relatively permanent normative commitments, such as fundamental rights and accountability, from technical specifications and implementation rules that may appropriately change as evidence accumulates. Their illustrations include Germany’s staged introduction of digital-health legislation, adaptive mechanisms within the EU AI Act, and the five-year congressional reauthorization cycles for FDA drug and device user fees.
The important insight is that agile legislation is not one unusually flexible statute; it is a coordinated governance system involving legislation, delegated rulemaking, standards, guidance, enforcement, and judicial review. The authors are also alert to the danger of technocracy: elected bodies must continue to establish goals and boundaries, while expert institutions generate evidence and make only bounded, reviewable adjustments.
Kahles et al., “Reforming IVDR Article 5(5).” This shorter commentary applies much the same philosophy to a highly specific and immediate problem: the European IVDR requirements governing in-house laboratory tests. The authors argue that the European Commission’s proposed reform should be understood as regulatory recalibration, not deregulation.
Most importantly, laboratories would no longer have to prove that no equivalent commercial CE-marked test is available before using an in-house IVD. The proposal would also permit limited transfers between health institutions for compelling public-health or patient-care reasons, reduce documentation requirements for laboratories accredited under ISO 15189, and extend the in-house exemption to certain central laboratories producing tests exclusively for clinical trials. Yet core obligations—quality management, safety and performance requirements, transparency, traceability, inspection, and incident oversight—would remain.
The paper’s caution is that shifting responsibility from premarket gatekeeping to institutional quality systems may work unevenly, particularly for high-risk, software-intensive, or algorithmic diagnostics. Success will depend on consistent interpretation, adequate inspection capacity, and careful policing of the boundary between clinical-trial testing and routine clinical use.
Common themes and insights. Both papers include Jochen K. (“Joe”) Lennerz, identified with Natera, and they share a recognizable regulatory philosophy. Regulation should not depend exclusively on a large, static barrier erected before a technology is used. Instead, safety can be protected through a lifecycle model combining qualified institutions, explicit accountability, real-world evidence, post-market monitoring, periodic reassessment, and bounded authority to adjust technical requirements.
In the broader paper, this becomes a general theory of “agile legislation”; in the IVDR paper, it becomes a concrete proposal to replace an overly rigid test-by-test restriction with accreditation, quality systems, traceability, and continuing oversight.
Neither article argues that innovation should escape regulation. Their stronger and more useful claim is that regulation should be designed to learn: preserve stable principles, permit controlled implementation, observe what happens, and revise the operational rules when experience shows that the original framework is unnecessarily burdensome, ineffective, or technologically obsolete. Lennerz’s corporate affiliation supplies a diagnostics-industry connection, but both articles frame their arguments principally around institutional design, patient safety, access, and the sustainability of diagnostic innovation.
Citations
Schneider NK, Stern AD, Price WN II, Lennerz JK. Can laws be flexible? Rethinking legislation for innovation. npj Digital Medicine. 2026;9:566. doi:10.1038/s41746-026-02846-5.
https://doi.org/10.1038/s41746-026-02846-5
Kahles A, Lennerz JK, Schirmacher P, Stenzinger A. Reforming IVDR Article 5(5): Will the European Commission’s proposal reduce regulatory burden for in-house IVDs? Health Policy and Technology. 2026;15:101284. doi:10.1016/j.hlpt.2026.101284.
https://doi.org/10.1016/j.hlpt.2026.101284
