Investing in Digital Health: Key Highlights and Unique Aspects

**Title:** Investing in Digital Health: Insights from a Lawyer and Investor in Life Sciences

**Description:** In this video, Sophie Pelé, a Lawyer and Partner at Dechert LLP, and Simon Turner, a Partner at Sofinnova Partners, discuss the unique aspects of investing in digital health. They provide valuable insights into the regulatory challenges and opportunities faced by companies in the digital health space. Watch this video to gain expert perspectives on the intersection of technology, life sciences, and legal considerations in the evolving field of digital health.

➤ [Source](source_link)


0:00 Introduction
0:35 Defining Digital Health
1:57 The Structure of Digital Health
3:25 Regulatory Considerations in Digital Health
6:12 The Flexibility of Regulatory Requirements
8:40 The 23andMe Case Study
10:45 Importance of Early Regulatory Planning in Health Tech

**Keywords/Tags:** [vid_tags]

**Full Transcript:**

[00:00] Thank you so much for joining us today. In this video, we will be discussing the particularities of investing in digital health from the perspectives of a lawyer in life sciences and an investor in life sciences. Joining us are two experts in this field. Sophie Pelé is a partner at Dechert LLP in Paris, specializing in regulatory issues. Simon Turner is a partner at Sofinnova Partners, with a focus on digital health and med tech. Sophie and Simon, over to you.

[00:35] Sophie: Thanks for having us. To set the scene, let’s talk about the broad scope of digital health. It encompasses everything from smartphone applications available on app stores to specialized digital therapeutics. For our discussion, we’ll break it down into three categories: enabling technologies, analytics, and treatments. Enabling technologies include digital twin modeling and care pathway management. Analytics focuses on more effective screening and diagnosis of patients. Finally, treatments explore the potential of technological means to elicit a biological response.

[01:57] Simon: That’s a great way to structure the discussion, Sophie. As a lawyer, the question of whether digital health falls under tech or life sciences is crucial. The legal infrastructure for a product varies depending on the answer. For example, let’s consider the case of an enriched version of a monitoring device within a hospital. If the data is purely tech-driven, it falls under one category. But if it’s used for diagnosing rare diseases, it becomes part of the life sciences field. Today, we’ll focus on hot topics related to this intersection.

[03:25] Sophie: Regulatory issues are often seen as hurdles in the life sciences field. Simon, from your experience in digital health, do you find regulatory considerations to be obstacles as well?

[03:45] Simon: That’s an interesting question. In digital health, regulatory requirements are more of a tactical or strategic choice for companies. It’s not an absolute must. In certain cases, companies in the well-being sector or non-medical fields have achieved success without needing regulatory approvals. However, for companies that require substantial data analysis or want to make medical claims, regulatory considerations become crucial. Going through the regulatory process not only provides credibility but also separates you from competitors who may not have the same level of evidence to support their claims.

[06:12] Sophie: It’s fascinating how digital health offers flexibility in terms of regulatory requirements. In traditional medical devices and biotech, there’s a linear approach where compliance is mandatory. In digital health, you have more freedom to choose when and how to navigate regulatory processes. It’s not a one-size-fits-all situation. Companies can strategically decide when to adopt regulatory measures based on their unique circumstances.

[08:40] Sophie: To convince skeptics, could you share an example of a company that had a negative experience with regulatory hurdles?

[08:55] Simon: Absolutely. A well-known case is that of 23andMe. Initially, they were providing genetic ancestry profiles, which fell under the well-being category. However, they started making medical claims without going through the necessary regulatory processes. As a result, the FDA intervened and imposed penalties. This case highlights the importance of following regulatory guidelines when making medical claims.

[10:45] Sophie: This example demonstrates that it’s never too early to consider the regulatory status of your product or service in the digital health space. Planning ahead and understanding the regulatory landscape can save companies from legal issues and setbacks.

**Learn more about investing in digital health:**

1. [Digital Health Investment Trends (Source)](source_link)
2. [The Regulatory Landscape of Digital Health (Source)](source_link)
3. [Key Considerations for Health Tech Startups (Source)](source_link)
4. [Case Study: Navigating Regulatory Challenges in Digital Health (Source)](source_link)

-Sophie Pelé Lawyer and Partner at Dechert LLP
-Simon Turner Partner at Sofinnova Partners

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