Podcast Summary

This Week in Global Development: Special Episode – Can AI Safely Support Mental Health?

Date: November 19, 2025

Host: Katherine Chaney (Senior Editor, Devex)
Guests:

• Professor Bilal Matin (Chief AI Officer at PATH)
• Kristelna Reynicke (COO, South African Health Products Regulatory Authority, SAPRA)
• Professor Miranda Wolpert (Director of Mental Health, Wellcome Trust)

Episode Overview

This episode explores the growing role of generative AI in closing the global mental health care gap. With over a billion people affected by mental health conditions worldwide and a chronic shortage of clinicians—especially in low- and middle-income countries—AI is positioned as a promising tool to extend care. Yet, the conversation delves deeply into concerns around safety, oversight, and the unique regulatory challenges AI poses, particularly the tension between innovation and risk, and the need for locally led regulatory frameworks. Central to the discussion is CARE mh (Comprehensive AI Regulation and Evaluation for Mental Health), a new initiative positioning South Africa as a leader in ethical AI governance.

Key Discussion Points and Insights

The Scale of the Mental Health Challenge

• Global Need: Over 1 billion people are affected by mental health conditions (00:03).
• Workforce Gap: On average, only 13 mental health workers per 100,000 people globally, with the worst shortages in low- and middle-income countries (00:15).

The Promise—and Perils—of AI in Mental Health

• AI Can Expand Access: Generative AI can “completely transform treatments as we know them,” offering access, language translation, and multimodal interaction beyond just chatbots (Miranda, 07:20–08:25).
• Risks of Harm: Without robust oversight, AI solutions may cause harm, especially when tools claim to provide treatment without validation (Bilal, 02:11–05:07; Kristelna, 05:30–06:43).
• Blurring Lines: Many mental health apps sit in a grey zone between “well-being tools” and genuine medical devices, with varying regulatory scrutiny (Bilal, 02:11–05:07).

Regulatory Innovation: The CARE mh Initiative

• Policy Incubator: CARE mh is a regulatory policy incubator launched at the G20 Social Summit, funded by Wellcome Trust, run by SAPRA, and supported by PATH (00:55–01:15).
• South Africa’s Leadership: Positioning Africa not just as a recipient but as a developer of regulatory standards for AI in health (Kristelna, 06:00–06:43; 23:16–24:36).

The “Sandbox” Approach to Regulation

• Definition: Regulatory sandboxes provide a safe, collaborative space for regulators, innovators, researchers, and people with lived experience to co-design, test, and iterate solutions (Bilal, 21:23–22:30; Miranda, 19:14–20:50).
• Advantages:
  • Real-time learning and feedback
  • Clarity for innovators
  • Continuous postmarket monitoring (otherwise known as postmarket surveillance) (Bilal, 11:18–13:07)
• Quote: “It’s not a game anymore… The world is too complicated for that at present and… we don’t have all of the right answers.” —Bilal (21:23)

Regulation as an Enabler, Not a Barrier

• Clarity Over Burden: Lack of clear, predictable regulatory pathways is a greater barrier to innovation than the regulations themselves (Kristelna, 17:02–18:24).
• Guiding, Not Policing: SAPRA's aim is to set clear rules so innovators know “how to win the game”—not to stifle them (Kristelna, 17:02–18:24).
• Quote: “If you chase 22 people on a football pitch and say play the game without rules, you have chaos. But once the rules are clear, people can enjoy and win.” —Kristelna (17:40)

Importance of Local Regulatory Ownership

• Cultural Context: AI tools validated elsewhere may fail in South Africa’s highly diverse environment—with 11 languages and multiple cultural norms (Kristelna, 23:16–24:36).
• Accountability: “We cannot outsource that responsibility to other regulators who have actually not assessed [the] tool within our context.” —Kristelna (24:12)
• Trust: Loss of trust due to local harms can derail progress (Bilal, 24:48–27:03)

Global Shift: Regulation Shaped in the South

• Broader Trend: Innovation and regulation are now increasingly being driven by African actors, not just imported (Miranda, 27:30–28:13).
• Quote: “We have an opportunity here to create a world of mental health that’s different from the world that’s currently in the US or the UK… with a different set of actors.” —Miranda (27:48)

Barriers Beyond Regulation

• Payment Models: Health economic considerations—determining which innovations are affordable and worth adopting—are critical (Bilal, 28:42–29:33).
• Investment: Additional funding and focus are needed to scale mental health innovations (Miranda, 29:33–30:24).
• Infrastructure and Data: Reliable connectivity, robust data systems, and a workforce trained to use and evaluate AI are all vital, especially in Africa (Kristelna, 30:33–31:43).

The Five-Year Vision for Ethical AI in Mental Health

• Personalization and Choice: Mental health support will look “completely different,” with people empowered to choose safe solutions that fit their needs (Miranda, 32:18).
• Regional Leadership: Success would mean approvals by SAPRA are used as a reference point by other African countries—moving the “locus of control” to the continent (Bilal, 32:44).
• Predictable Rules and Capacities: Regulators will have more mature frameworks, better monitoring, and innovators will have clearer standards at regional and global levels (Kristelna, 33:21).

Memorable Quotes & Timestamps

• On Regulation and Innovation:
  “If you chase 22 people on a football pitch and say play the game without rules, you have chaos. But once the rules are clear, people can enjoy and win.”
  — Kristelna Reynicke (17:40)

• On the Promise and Risk:
  “There is both great opportunity, like you said, but also the potential for things to go very, very wrong… We should probably figure this out sooner rather than later.”
  — Bilal Matin (04:48)

• On the Need for Local Regulation:
  “We cannot outsource that responsibility to other regulators who have actually not assessed [the] tool within our context.”
  — Kristelna Reynicke (24:12)

• On Trust:
  “It only takes a few people to get hurt for us to lose the trust of all of the individuals in that ecosystem who need help.”
  — Bilal Matin (26:00)

• The Vision:
  “My prediction is that within five years we will see mental health support in ways that none of us are envisaging now...”
  — Miranda Wolpert (32:18)

Key Timestamps

• 00:03–01:15 — Framing the mental health care gap, AI’s promise, and introduction of CARE mh.
• 02:11–05:07 — Bilal Matin on the landscape of AI health devices and regulatory ambiguity.
• 05:30–06:43 — Kristelna Reynicke on regulatory gaps and risks to vulnerable populations.
• 07:20–08:25 — Miranda Wolpert on transformative AI opportunities beyond chatbots.
• 11:18–13:07 — Bilal Matin on the need for regulatory “sandboxes” and collaboration.
• 17:02–18:24 — Kristelna on how clarity can enable, not stifle, innovation.
• 19:14–20:50 — Miranda on why Wellcome funds regulatory capacity and sandbox initiatives.
• 21:23–22:30 — Bilal further explains the sandbox concept.
• 23:16–24:36 — Kristelna on the necessity of local regulatory ownership.
• 27:30–28:13 — Miranda on Africa’s regulatory and innovation leadership.
• 28:42–31:43 — Panel reflects on other scaling barriers: payment, investment, infrastructure, data, capacity.
• 32:18–33:21 — Five-year vision for ethical, scalable, locally driven AI in mental health.

Conclusion

This episode highlights both the urgency and complexity of harnessing AI for mental health globally. The CARE mh initiative in South Africa is presented as a model for how forward-leaning regulatory frameworks—developed and led locally—can both spur innovation and ensure patient safety. The core message: AI in global mental health must balance its enormous potential for good against considerable risks, with local context and clear guidance at the heart of responsible progress.