Trend 1 = AI moves from “innovation topic” to “regulated evidence lifecycle”

What’s changing (in 2021): This trend is largely not operational yet in the June–December 2021 reports. AI is not showing up as a defined evidence lifecycle topic with governance expectations in the way it does later.

Seen in (or not seen in): Across the June–December 2021 set, the dominant themes are RWD quality, registries, ethics processes, and data protection—not AI governance frameworks. (So for 2021, this trend is best treated as not yet a visible regulatory driver within the monthly reporting window.)

So what? For the 2021 baseline, the important takeaway is absence: teams were building “RWE fundamentals” (data quality, registries, ethics routing) rather than AI-specific controls.

Trend 2 = Health-data access and interoperability become regulatory infrastructure

What’s changing: Early signs of health-data access becoming more structured and inspectable—via formal platforms, system controls, and visibility requirements.

Seen in:

• France (CNIL MR-004 update): projects compliant with MR-004 must be registered in a public directory maintained by the Health Data Hub (PDS).
• June-RWR-Reg-Updates-compressed
• UK (NHS Digital GPDPR pause): rollout paused due to concerns about public awareness and how data would be used—an early signal that “secondary use” depends on trust and communication, not just legality. 
• Norway: amendments intended to improve access to medical records (direction of travel toward access enablement).

So what? Even in 2021, “data access” starts to look less like an informal feasibility question and more like a governed pathway, with visibility, registration, and public confidence becoming practical dependencies.

Trend 3 = Harmonisation of NIS/RWE methodological expectations accelerates

What’s changing: 2021 is very strong on method and data quality signals—regulators begin reducing ambiguity around what “acceptable” RWD/RWE looks like.

Seen in:

• FDA draft guidance (EHR/claims to support regulatory decision-making): emphasises data provenance, QA/QC planning, data management documentation, and transformation controls.

• The September report explicitly notes this as reducing guesswork about what is considered “regulatory grade” in this context.

• EMA registry-based studies guideline and related positioning around registries and suitability criteria are repeatedly referenced across late 2021 materials. 

• MHRA (Dec 2021): guidance on use of RWD in clinical studies to support regulatory decisions, including an RWD-based RCT guideline—framing “regulatory acceptability” around answering the regulatory question (not the “type” of data alone). 

So what? For the 2021 baseline, this is the clearest trend: the year moves from “RWE can be useful” to documented expectations around data quality, provenance, and design choices that answer regulatory questions.

Trend 4 = Data protection and cybersecurity directly shape RWE feasibility

What’s changing: Data protection starts to show up as a real-world constraint on secondary use—particularly where trust, cross-border flow, and governance transparency are at stake.

Seen in:

• EU–UK data adequacy decision (enabling cross-border personal data flows).
• UK GPDPR pause due to concerns about communication and public awareness—an early example of acceptance/trust affecting feasibility. 
• France CNIL MR-004 update strengthening “public directory” visibility for compliant projects (governance and transparency expectations). 

So what? By late 2021, it’s already visible that lawful basis alone is not enough—trust, transparency, and clear governance artefacts can determine whether data programmes proceed.

Trend 5 = Operational standardisation increases predictability—but reduces flexibility

What’s changing: 2021 contains many “operational mechanics” updates—ethics submission rules, templates, platform changes, and classification guidance. These look small month-to-month, but they collectively standardise how studies get approved and run.

Seen in:

• Latvia: submission requirements tightened (signature / scanned or e-signature). 

• Spain: consent/GDPR annex updates (ICF expectations pulled into standardised annex structure).

• UK: HRA REC SOP update affecting progress-report expectations for proportionate review (relevant to non-CTIMPs).

• UK (IRAS): guidance being prepared on set-up of non-interventional research activity at NHS/HSC organisations (process formalisation signal).

• Spain: AEMPS/CEIm “Memorandum” providing detailed expectations and templates for observational studies with medicinal products. 

So what? This is the operational baseline forming: fewer “informal norms,” more documented process steps, defined expectations, and templates—which sets up later years’ heavier standardisation.