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The recently passed Washington My Health My Data (MHMD) Act stands as a significant legislative milestone, reshaping data requirements for pharmaceutical companies and raises a new specter of non-compliance. Against a backdrop of increasing regulatory scrutiny and privacy concerns, understanding the implications of the MHMD Act is a critical first step and learning that they may not be in compliance is weighing on the minds of CEOs, CMOs and Chief Privacy Officers (CPOs) across the industry. Compliance Officers are asking what the impact of the MHMD Act will be, and, more importantly, how can they ensure that their companies are aligned with changing regulations?

What is the Legislation?

Enacted on March 31, 2024, the Washington My Health My Data Act represents a comprehensive framework aimed at enhancing health data ownership and privacy. Key provisions of the MHMD Act include obtaining explicit authorization from consumers before selling or sharing their health data, expanding the definition of health data to encompass various aspects of physical and mental health, increased transparency regarding data privacy practices, and stricter accountability measures in case of breaches or violations including enforcement actions by the Attorney General and private litigants.

Of course, the MHMD Act has profound implications for pharmaceutical companies, reshaping their approach to data privacy and compliance. In an industry characterized by stringent regulations and waning consumer trust, adherence to the MHMD Act is critical for several reasons, not the least of which being Regulatory Compliance. Healthcare companies operate within a complex regulatory landscape, subject to oversight from federal agencies such as the FDA, FTC and DEA. The MHMD Act introduces additional compliance requirements, necessitating proactive measures to ensure adherence and avoid negative PR and costly penalties.

Identifying the source of one’s FOFO: Fear of Finding Out

Pharmaceutical companies, their agencies, and internal compliance have always been a critically important part of program execution, but the stakes have just gone up. In fact, in this new compliance environment, one could now consider a proactive approach to data compliance management as a competitive advantage for the business. Specifically, the companies with the right approach and toolset to automate workflow, will have a new competitive advantage whenever engaging in marketing programs and at all digital consumer touchpoints. It also means the end of FOFO, because finding out about your level of compliance shouldn’t be a fearful situation.

Shailee Vimadalal, a partner at ZS Associates is a global management consulting and technology firm specializing in transforming healthcare and beyond said about these marketplace changes, “The Washington My Health My Data Act (MHMD) brings a renewed focus on consumer consent for data use by the US pharmaceutical industry. This necessitates investments in personal data collection and handling practices to ensure greater transparency, commitment, and control for the consumers on how their data and how it is being used. Implementing a robust consent and preference management solution can be a strategic step for pharma companies to navigate this evolving landscape.”

In the pharmaceutical industry, ignorance is never an acceptable reason for being out of compliance. In addition, once a company becomes aware of an issue, its leaders are obligated to act. 

This draws a direct line from the CEO to the office of Compliance and across to the head of IT as Data Management challenges begin to emerge. Pharmaceutical companies handle vast amounts of sensitive patient data, including clinical trial results, medical records, and adverse event reports. Laws like this touch even simple “request more information” type functionality on product websites and extend throughout all brand digital media. Compliance with the MHMD Act requires attention to robust data management systems to safeguard the privacy and security of this information.

This Washington act will also impact Marketing Practices. The MHMD Act's provisions for consumer authorization and data-based targeting have significant implications for pharmaceutical marketing strategies. Companies must ensure compliance with opt-in requirements and adopt data privacy-centric approaches to these campaigns while ensuring strict compliance with data-usage disclosures. In other words, proactive and skillful compliance in marketing workflows will become a key strategic and tactical competitive advantage for pharmaceutical brands in 2024.

Pete Dannenfelser, a pioneer of digital healthcare marketing communications, offers insights into the impact of the MHMD Act on pharmaceutical company compliance. “The industry's historical commitment to conservatism and caution may make change easier. But the consequences of non-compliance underscores the importance of leveraging tools to assess the current state of a company’s digital platforms and readiness for what’s next.” 

Dannnfelser goes on to say, “While these newly enacted requirements will hit the entire industry, pharmaceutical companies operating under Corporate Integrity Agreements (CIAs) must be able to act quickly to uphold stringent compliance standards. Non-compliance with the MHMD Act could jeopardize adherence to CIAs, leading to severe consequences.”

Amidst the challenges posed by the MHMD Act, Dannenfelser recommends leveraging new AI-powered digital tools to navigate compliance requirements effectively. In fact, adding these powerful new tools to workflow should foster a competitive advantage, not only in day-to-day tactical execution, but also with strategic planning in a rapidly evolving new regulatory environment.

“Advertisers can only effectively manage what they can measure, so optimal integration of compliance standards into workflows become an essential element of all digital media campaigns and web properties,” says Jamie Barnard, CEO of COMPLIANT, the industry leader in AI SaaS compliance software.

A.I. algorithms analyze vast amounts of data to assess compliance risk levels, identifying potential areas of non-compliance and guiding companies in prioritizing remediation efforts. These learnings can help pharmaceutical companies create comprehensive compliance roadmaps, outlining steps to ensure compliance with data privacy regulations, opt-in requirements, and data-based marketing practices. Beyond that, AI technologies enable real-time monitoring of compliance activities, allowing companies to detect and address compliance issues promptly and proactively, minimizing the risk of regulatory violations and associated penalties. As any seasoned Rx marketer can tell you, a little proactivity can go a long way when dealing with regulatory bodies. 

The Washington My Health My Data Act ushers in the next era of significant regulatory data requirements with far-reaching implications for the healthcare industry among others. So, what should pharmaceutical companies be doing now to manage FOFO and stay ahead of this and other emerging data laws?

• Embrace A.I.-driven tools to reactively assess active current content and proactively review new digital assets.

• Adopt proactive compliance strategies leveraging tools and revising policies to be flexible enough to change with new laws.

• Respond quickly when issues are identified – oftentimes, the remediation is not as intimidating as it seems, especially if repeatable processes and guidance is enacted.