—
How to speak to your CCO about mobile device compliance
Making the business case for mobile device compliance solutions in healthcare and life sciences
—About Global Relay
Introduction
Step 1 Discuss current and future risks
Step 2 Perform a risk assessment to pinpoint company needs
Step 3 Highlight recent regulatory actions and guidance
Step 4 Secure buy-in from other business units
Step 5 Suggest potential solutions
Conclusion Build the business case
Why choose Global Relay for healthcare and life sciences?
Compliance teams have always operated in an environment of challenged resources. Senior leaders can be reluctant to allocate funds or staff beyond the bare minimum, and with communications technology continuing to evolve rapidly, the challenges are beginning to compound for healthcare and life sciences companies as they work to remain compliant.
Mobile devices present some of the largest problems for compliance teams, regardless of whether they issue corporate devices or implement a bring-your-own-device (BYOD) policy. With the right approach, you can demonstrate to leadership how proactive investment in mobile device compliance reduces long-term costs, prevents reputational harm, and increases business agility across your organization.
Use this guide to help structure a conversation about mobile device compliance with your Chief Compliance Officer (CCO), or other business leads. Let’s take a closer look at each step.
Back to contents
Regulations are constantly adapting to keep pace with evolving technology—so your compliance infrastructure should too. Where companies were once only expected to monitor a handful of official channels, teams today conduct business across a complex digital and mobile landscape—from ephemeral messaging apps to social media channels and countless on-the-go collaboration platforms in between.
Begin the conversation by highlighting specific communications risks that your company may already be exposed to through mobile devices. Make sure to anchor your points with real-world scenarios that resonate with your CCO’s oversight responsibilities.
Emphasize how an inadequate mobile device compliance policy could expose your organization to the following risk areas (which can create civil and criminal liabilities):
Unmonitored mobile devices
Ephemeral messaging apps
Social media platforms
Kickbacks and insider trading
Recordkeeping requirements
Unmonitored mobile devices High-risk employees, such as sales reps and intellectual property (IP) holders, often use personal smartphones or poorly monitored company-issued devices to send messages, join meetings, and share files. Without thorough compliance policies in place, these communications may avoid detection completely, putting your company at risk.
Ephemeral messaging apps Mobile channels, such as WhatsApp, Signal, and Telegram, are popular among distributed sales reps and third-party vendors—but features like ephemeral messaging create significant barriers to recordkeeping and eDiscovery.
Social media platforms Informal outreach, such as a LinkedIn posts from a sales rep, can constitute a business communication that’s subject to recordkeeping rules. If your archiving system isn’t equipped to capture these channels, your organization is at risk if it’s ever audited.
Kickbacks and insider trading Inadequate monitoring can also leave companies unaware of illegal employee behavior, such as kickbacks, insider trading, and other off-book agreements. The cost of these transgressions can be steep, but regulatory guidance states that proof of proactive monitoring may help decrease penalties.
Recordkeeping requirementsMany healthcare and life sciences organizations maintain records or digital signatures, subjecting them to FDA regulations (such as 21 CFR Part 11) that require strict controls over access, data accuracy, and audit trails. Many outdated data governance systems—and most manual workflows—are not up to standard.
Now that you’ve established a potential risk environment, you’ll want to evaluate how your own organization stacks up. A structured risk assessment will help move the conversation from exploring what could happen to identifying what’s already happening (or worse, what might be happening).
Start by cataloging the communications channels your company uses for business purposes, including SMS, email, phone, video apps, messaging apps, and social media. Review which tools (if any) you have in place to monitor, archive, and audit those channels.
Are personal or unmanaged devices used by sales, marketing, or clinical teams?
Are all cloud-based collaboration tools (e.g., Zoom, Microsoft Teams, and Salesforce Chatter) monitored and recorded?
Are there hidden or unexpected apps (such as trading platforms) that employees may be using for business communications?
How is your data governance structured? Do you know every instance where your data travels?
Do your monitoring procedures match actual usage patterns?
Interview key stakeholders in sales, medical affairs, and regulatory affairs teams to gather anecdotal insights about how they typically communicate. Often times teams share workarounds they use to speed up communication; but these shortcuts may bypass official monitoring systems. These ground-level insights not only help quantify risk but also strengthen your case for investing in tools that support everyday workflows.
Top tip
Look for anomalies. For example, if current capture rates for a specific channel seem suspiciously low, employees may be using these channels on unmonitored devices.
Now that you’ve covered the general risks of mobile device communications and how your own company could be vulnerable, you should review recent regulatory action and assess whether any of it is relevant to you. U.S. regulations of note here include Securities and Exchange Commission (SEC) Rules 17a-4 and 17a-3, Food and Drug Administration (FDA) Title 21 CFD Part 11, the Sunshine Act, and a recent Department of Justice (DOJ) amendment to its Evaluation of Corporate Compliance Programs (ECCP).
Reputational damage following 21 CFD Part 11 warning letters
Even if your company manages to avoid fines for a recordkeeping violation, a warning letter for breaching The FDA’s 21 CFD Part 11 (a U.S. regulation concerning how healthcare and life sciences companies create and maintain electronic records) could still greatly affect you during the research and development and growth stages. A 21 CFD Part 11 violation comes with multiple risks, including immediate disruption to product manufacturing, removal of marketing authorization for up to 12 months, increased future scrutiny from the FDA, and immediate reputational damage.
For example, after the medical device company iRhythm received a warning letter from the FDA for a 21 CFD Part 11 violation, shares fell 25% the next month. This devaluation is widely attributed to the warning letter surfacing on the first page of Google results when searching the term “iRhythm.” This is just one example of how non-compliance can drastically affect a business’ bottom line—even if no fines or penalties are issued.
Data governance and proactive self-disclosure under the DOJ’s ECCP
The ECCP amendment specifies how companies should capture and retain all communications data, particularly for new channels that allow ephemeral messaging. Most importantly, the amendment highlights the importance of having a proactive compliance program. How robust your compliance policies and workflows are can influence the regulator’s decisions when evaluating corporate offenses. Although this may seem like a simple requirement, there are many atypical situations in which illegal activity may slip through the cracks.
For example, Pfizer accrued a $60 million fine in January 2025 after it acquired Biohaven in 2022. The acquisition included Biohaven’s violations of the Anti-Kickback Statute, which involved their Nurtec speaker programs. Pfizer terminated the programs once it acquired Biohaven but didn’t report the illegal activity to the DOJ. Pfizer’s specific compliance policies at that time are unknown, but if it had retained communications data from before the acquisition and proactively reported the violations to authorities, it’s likely that its 2025 fine would’ve been reduced significantly (as per the DOJ’s Voluntary Self-Disclosure Policy).
Misleading statements and off-label marketing on social media
Several pharmaceutical companies have been penalized for their employees and/or contractors promoting false or misleading information about drugs on social media. In May 2025, Sprout Pharmaceuticals received a warning letter from the FDA after its CEO made a post on Instagram that lacked proper risk information. The FDA also issued warning letters to Kaléo, Inc. and Merz Pharma for celebrity endorsements that omitted risk information and used misleading hashtags, respectively.
Social media promotion presents several challenges. Character limits can severely hamper proper disclosures, and the ephemeral nature of some 24-hour post formats can create challenges for capturing and retaining advertising communications—all of which must be submitted to the FDA as marketing material under 21 CFR Part 314. Using hashtags, emojis, and other special formatting common to social media can mislead consumers and land your company in hot water with the regulator. Even smaller interactions, such as liking a post or leaving a single-word response to a comment, could be seen as an endorsement of off-label marketing or other illegal behavior.
Start by identifying the key stakeholders outside of compliance who depend on reliable access to communications data or have a vested interest in mitigating risk.
Communications compliance doesn’t exist in a vacuum. To increase the likelihood of approval, you should position potential solutions as business-wide solutions—not just a compliance fix. Demonstrate how upgraded mobile device compliance solutions can deliver cross-functional benefits to departments across your organization.
Legal
Lawyers and legal professionals are responsible for interpreting regulations and ensuring policies align with local and global requirements; they have a natural interest in new compliance solutions. By keeping all business-related communications (including mobile communications and social media interactions) properly captured and retrievable, legal teams can proactively manage risk and meet disclosure obligations.
Clinical operations
Clinical teams, such as researchers, trial managers, and site coordinators, routinely use mobile devices to communicate with other internal teams and external partners. These communications may involve sensitive patient data, trial protocols, or vendor coordination. Emphasize how compliant mobile workflows can protect data integrity, streamline audit readiness, and support remote and hybrid clinical models without compromising regulatory obligations.
HR and employee experience
HR teams are responsible for onboarding, maintaining employee privacy, and clearly communicating and enforcing acceptable use policies. A mobile compliance solution with configurable permissions and user-friendly interfaces supports these needs while minimizing disruption to employee workflows. HR is also a valuable ally in training and enforcing new policies, so support from this department will be crucial down the line.
Medical affairs
These professionals engage in scientific exchange with healthcare providers and key opinion leaders, often through mobile channels and third-party messaging apps. Because their communications must remain non-promotional and scientifically accurate, compliance oversight is key. A mobile device compliance solution helps ensure these engagements are documented and reviewable, reducing regulatory risk while preserving the flexibility these employees need in the field.
Commercial and field teams
Gaining support from commercial leads (e.g. sales, marketing, and medical affairs) is essential. Show how compliance tools can be implemented without slowing down day-to-day operations. The most successful compliance policies are those that support rather than restrict operations. This includes tools that enable full communications capture and compliance adherence while allowing reps to keep using familiar apps and workflows.
PR and corporate communications
Social media and mobile-accessible messaging platforms are commonly used for corporate announcements, media relations, and crisis communications. These functions must be conducted compliantly to avoid reputational and regulatory consequences. A mobile compliance solution that captures content across all messaging platforms ensures communications are archived, searchable, and defensible—whether they originate from official accounts or mobile devices. Demonstrating this capability can win support from teams focused on brand protection and external transparency.
IT and cybersecurity
These teams manage device provisioning, mobile device management, access controls, and technical safeguards and security infrastructure. IT and cybersecurity leaders want solutions that support secure device management, encryption standards, and secure APIs for scalable cloud-based apps.
IT teams are also often tasked with shadow IT prevention, which involves the elimination of unauthorized tools and applications that bypass corporate oversight. A mobile compliance platform that automatically detects and captures communications from shadow applications helps IT meet these goals.
Security and risk management
Risk officers and security professionals are tasked with reducing organizational exposure to fraud, data leaks, and regulatory violations. This is the bread and butter of your CCO’s oversight. By framing your proposal to mitigate risk, particularly the risks associated with mobile devices, you appeal directly to their priorities.
Include stakeholder interviews in your proposal to show cross-departmental alignment. Capture shared pain points or success metrics that resonate across functions.
Tie in everything you’ve previously touched on by highlighting industry-standard technologies that cover your identified business needs. Focus on technology platforms and policy enhancements that directly address the vulnerabilities you identified in the earlier risk assessment and any technologies that you know senior leadership is eager to develop—such as AI-enabled solutions.
Mobile device capture
Which solutions capture your most-used communications channels (e.g. SMS, WhatsApp, Apple® Messages) without disrupting the employee experience?
AI-enabled technology
Are there AI capabilities in place to detect unusual communication patterns, potential insider threats, or regulatory red flags in real time? AI is one of the leading technological innovations of the 2020s, and every forward-looking executive is considering how their company can take advantage of it.
Archiving and eDiscovery
Do these solutions offer cloud-based archiving and eDiscovery functionality tailored to healthcare and life sciences regulations? This means adhering to the highest standards of data security, including how data is encrypted both at rest and in transit, and where that data resides. Healthcare and life sciences regulations often require that business and customer data remains in the country of origin or a country with data sovereignty protections.
Collaboration tool coverage
Ensure solutions can ingest data from Microsoft Teams, Zoom, Slack, Salesforce Chatter, and any other platforms your teams use.
Data governance and audit trails
Evaluate whether a platform supports auditability, version control, and data retention policies that align with regulations like 21 CFR Part 11. How a solution provider archives and structures data for easy retrieval is crucial for this point.
Communications monitoring
Advanced communications monitoring solutions allow your employees to use the channels they prefer, while ensuring your communications data is captured and stored securely and flagged for potential risks in real time. This way, you can address risks before they snowball into civil or criminal liabilities.
Go beyond describing the upfront offerings of different solutions. Include qualitative evaluations, such as ease of deployment, integration with existing systems, regulatory certifications, vendor credibility, cost estimates, and resource requirements.
While senior leaders within your company may instinctively deprioritize compliance spending, you can demonstrate return on investment for mobile device compliance by showing how the cost of inaction can be far greater than the cost of implementation. Some concrete benefits that could resonate with your CCO, Chief Financial Officer (CFO), and general counsel include:
Avoiding costly fines and litigationNon-compliance with recordkeeping rules can result in six-figure enforcement actions.
Gaining efficiency Centralized mobile data capture reduces the time and manual effort of audit prep and legal holds.
Protecting your reputation One data breach or investigation involving unmonitored mobile communications can significantly erode customer trust.
Reducing future regulatory risk The DOJ, the FDA, and global regulators continue to scrutinize digital communications. Being proactive reduces risk exposure over time.
The right positioning logically showcases how proactive investment in mobile device compliance cuts long-term costs, prevents reputational harm, and increases business agility across your entire organization.
For over 25 years, Global Relay has been providing recordkeeping and risk mitigation solutions for the most highly regulated industries. We understand the risks posed to your organization and equip you with the tools you need to manage them.
Our suite of mobile device compliance solutions helps healthcare and life sciences organizations like yours:
Meet mobile data retention and preservation requirements for both corporate device and BYOD policies.
Ensure robust digital communications governance to boost efficiency and resilience
Detect bad conduct and emerging risk
LEARN MORE
Find specific data when it matters most
