Ethical Genomics: The Key to Sustainable Innovation

The health genomics industry is at a point where the implementation of new data is intersecting with profound ethical responsibilities. Recent examples of costly mistakes, such as the ethical issues surrounding the recent 23andMe bankruptcy (1) underscore the obligatory role of thorough ethical planning for precision medicine and genomic services implementation in the real world. For entrepreneurs and established companies that wish to enter this new field, considering ethics is fundamental, as it could be the difference between long-term success and costly failure.

In contrast to regular healthcare data, genomic information does not only present an insight into current health; rather, it is able to predict future risks, discover family relationships, and reveal ethnic origin (2,3). Sharing DNA data online might seem like a personal endeavor, but it usually affects a large number of people. If a precision medicine or genomic company makes a mistake or does something unethical, private information about the whole family can be exposed. One particular example is the case of the 23andMe data breach in 2023 that affected 6.9 million users (5,6). In addition, it does not only mean a possible financial disruption, such as class-action lawsuits, also leaves a lingering stain on their reputation

Regulatory Oversight Is Intensifying Worldwide.
The European Union's European General Data Protection Regulation (GDPR) treats genomic data as particularly sensitive personal information requiring enhanced protection (4). In the United States, the Genomic Data Protection Act dictates how genetic data collection is regulated (6). In Mexico, the protection of human genomic data is primarily established through two key legal instruments: the Genomic Sovereignty Act (specifically Title 5 Bis, Articles 103 Bis) (7) and the recently updated Federal Law for the Protection of Personal Data Held by Private Parties. Both legal instruments explicitly classify genetic information as sensitive personal data and mandate its confidentiality. However, in practical terms, enforcement remains inconsistent, particularly with respect to the handling of genomic data in electronic form or its transfer across international borders. Existing provisions appear more focused on regulating the unauthorized extraction or physical export of genetic material than on addressing the complex challenges posed by digital data flows. Consequently, while the legislation formally recognizes the importance of safeguarding genetic information, its coverage in practice is less comprehensive and, in certain respects, less robust than comparable international frameworks.

Business Case: Ethics as Competitive Advantage
Leading genomics companies that engage in ethical practices create significant competitive advantages (2). Companies positioning themselves as ethical alternatives to ruthless data-mining competitors are successfully attracting both customers and top talent by emphasizing patient interests over short-term profits. This "ethics as competition" approach helps companies:
•    Attract top talent who want to work for an organization with a social-aware mission.
•    Build customer loyalty in a market that is becoming more aware of privacy concerns.
•    Boost investor confidence from funds prioritizing sustainable, responsible investments and avoid costly later litigations.
•    Navigate regulatory approvals more efficiently by demonstrating proactive compliance.

The Hidden Costs of Ethical Failures
The consequences of ethical missteps extend far beyond regulatory fines. For example, when third-party platforms controlling genetic data face bankruptcy or acquisition, customers lose access to their information and companies lose their competitive datasets (7). A clear data policy and long-term security of genomic resources is indispensable. In addition, companies that store proprietary variant classification algorithms and patient datasets on platforms controlled by third party entities risk exposing valuable intellectual property during industry consolidation events, even when the third party is not a direct competitor (7). Finally, it is important to note that, as regulatory frameworks evolve, companies with strong ethical guidelines will gain preferential access to markets and most important, government contracts, while those with weaker standards face increasing restrictions.

Core Ethical Imperatives for Genomics Entrepreneurs

1. Data Sovereignty and Control: It is of utmost importance to provide patients control over their genetic information This means implementing systems that allow individuals to access, modify, and delete their data easily, and providing explicit and clear guides to this end (9). New solutions are being tested, such as blockchain-based implementations that enable "self-sovereign identity," and allow patients to control exactly who accesses their information and for what purposes (10,9). It has even been suggested that every person should have the right to profit from their data (11). In addition, maintaining clear data governance frameworks that specify exactly how genetic information will be used, stored, and shared is a key process (12). Diverse national genomics initiatives demonstrate that robust data governance requires defining clear principles such as ensuring information is "secure, used to its full extent, fit-for-purpose, and valued" (12). Models based on local or international frameworks are required from the beginning of the enterprise in order to avoid later problems

2. Transparent Consent and Communication: It is recommended that genetic companies transition from a traditional informed consent to dynamic consent models that allow ongoing patient engagement with their data (9). Going beyond the initial statement and the ability to withdraw the person's data could contribute to later opportunities for research and precision medicine implementation that were not considered at the time. 
One of the most important things to consider is to communicate risks and benefits clearly without falling into the trap of genomic exaggerations of the value of the services provided, avoiding the so-called “recreative genomics” label (13). Companies must balance legitimate excitement about genomic potential with honest acknowledgment of current limitations and future uncertainties. This will help to increase the public confidence in the services provided and avoid future litigation.

3. Equity and Access: The genomic databases that power personalized medicine suffer from significant representation gaps, with most data coming from populations of European ancestry (1). There are now several institutions that have databases representing Mexican populations that should be used to create and replicate algorithms and diagnostic tools. In addition, there is an absolute requirement for those attracted to create or implement artificial intelligence products, since it has been reiteratively demonstrated that European data cannot be directly applied to other populations. Even when there is a well-described tool, entrepreneurs who prioritize diverse data collection create more accurate, clinically relevant products while addressing fundamental justice concerns. It is also important to consider pricing and access strategies that prevent the creation of "genetic elites." Companies developing breakthrough diagnostic tools and therapies must balance commercial viability with equitable access to personalized diagnosis and life-saving treatments. Otherwise, not only will the entrepreneur create disservice to society disservice, but they be liable for public image challenges and even exclusion from government contracts.

4. Long-term Societal Impact: It may be worth considering how the technology could influence spheres well beyond its immediate market value. Such effects might manifest in shifts to community dynamics, or alterations in established professional routines. In the medical field in particular, the potential disruption in several specialties is a reality. The full scope of these implications is rarely obvious at the beginning, and a careful examination may reveal both promising avenues and unintended consequences. For example, CRISPR entrepreneurs and innovators should consider questions about human enhancement, societal opposition, environmental release of modified organisms, and intergenerational effects of genetic modifications, in order to be considered a real contender in the field. Public image is rather important for companies providing genomic and precision medicine services.

Practical Implementation Strategies

Establish Ethical Infrastructure Early: It is important to consider the creation of governance frameworks before needing them. Implementing data access committees, establishing clear policies for returning results to participants, and developing protocols for managing incidental findings are required (12). As stated previously, the more affordable solution is to associate with a public entity to provide solutions that would help in this regard. Also, investing in security architecture that treats genomic data as uniquely sensitive should not be avoided [6]. This includes end-to-end encryption and role-based access controls, for the most sensitive applications to preclude unauthorized use of the data. Expensive at first, but cheap in the long run.

Build Stakeholder Engagement: In order to build engagement, a first must it to develop ongoing relationships with patient advocacy groups, bioethicists, medical associations and regulatory bodies. These relationships provide early warning of emerging concerns and help shape genomic industry standards. Similarly, it is rather useful to practice transparent communication about your research goals, methodologies, and findings. 

The Path Forward
The genomics sector appears to be entering a critical phase. The way companies approach ethics could shape not only their reputation, but also their long-term competitiveness. Entrepreneurs or established companies who weave ethical reasoning into the very fabric of their operations may find themselves better equipped to handle regulatory complexities and shifting public expectations and new developments, as is expected due to the fast pace of precision medicine research. This should start with the core business model and extend through product design, data stewardship, regulatory oversight and market strategy.

Such an approach is not merely about compliance. It influences investor confidence, fosters durable trust among patients and research participants, secures the normative compliance and positions the company to meet the demanding social responsibilities inherent in working with human genomics and precision medicine.

The question is not if prioritizing ethics in health genomics has an intrinsic value, but if the entrepreneur will lead the industry toward responsible innovation or just follow others who were able to have this insight in the first place. In a field where technology literally touches the code of human life, ethical leadership is not just the practice of good business, but the essential stewardship of humanity's health and genomic future.

Bibliography

1) https://www.washingtonpost.com/technology/2025/07/17/23andme-bankruptcy-privacy/
2) Diversity, Profit, Control: An Empirical Study of Industry Employees. https://pmc.ncbi.nlm.nih.gov/articles/PMC10194829/
3) Protecting Privacy of a New Corporate Asset: User DNA https://btlj.org/2025/01/protecting-privacy-of-a-new-corporate-asset-user-dna/
4) Legal aspects of privacy-enhancing technologies; https://genomebiology.biomedcentral.com/articles/10.1186/s13059-024-03296-6
5) Data privacy and genetic testing; https://iapp.org/news/a/the-dna-of-privacy-and-the-privacy-of-dna
6) Bipartisan Genomic Data Protection Act Reintroduced in Senate https://www.hipaajournal.com/genomic-data-protection-act/
7) Why Data Ownership Matters in Genomic Analysis; Golden Helix https://www.goldenhelix.com/blog/taking-control-of-your-data-why-ownership-matters-in-genomic-analysis/
8) https://www.diputados.gob.mx/sia/coord/OBRA_LEG_LIX/obraleg_lix/inic/htm/02dic03_3.htm
9) Balancing the safeguarding of privacy and data sharing: perceptions ... https://www.nature.com/articles/s41431-022-01273-w
10) Ethical Considerations in Genetic Research | AttoDNA https://www.attodna.com/blog/2024/9/ethical-considerations-in-genetic-research/
11) The patient will see you now : the future of medicine is in your hands. Eric Topol. Basic Books 2014, ISBN 0465054749
(12) Governance of genomic data; Melbourne Genomics Health Alliance https://www.melbournegenomics.org.au/about-us/our-work/project-portfolio/data-and-information/governance-genomic-data
(13) Ethics In Genomics Healthcare & Research https://www.nuffieldbioethics.org/wp-content/uploads/FINAL-version-Genomics-workshop-summary-and-analysis.pdf