In the HealthTech world right now, compliance doesn’t feel simple anymore. It’s not just about ticking one box and moving on. When a firm is operating in both the United States, and Quebec, the regulations may begin to become complex and even bewilding. There is HIPAA, which is not new to the majority of digital health teams in the United States. On the flipside, in Quebec, there is Loi 25 that introduced more recent and difficult to fulfill privacy expectations.
For startups trying to grow fast, and even for more established platforms, the pressure is real. It’s not only about understanding what each law says. It’s about building systems that can actually handle both at once, without slowing everything down or making product teams frustrated.
Understanding the Regulatory DNA
HIPAA is not a new component of the U.S. healthcare. It dwells upon the secured health information and describes the method of its protection by the covered entities and business associates. The administrative safeguards, the technical safeguards, the physical safeguards, and a great deal of documentation are all available. To consultants in many HealthTech businesses, achieving HIPAA certification seems to be a significant milestone. It demonstrates that the company is not a joke, is organized, and willing to collaborate with hospitals or insurers.
Bill 64 is now known as Loi 25 that transformed the privacy scene in Quebec. It is not limited to healthcare only. It extends to personal information more generally, thereby making HealthTech companies that serve the residents of Quebec automatically fall within the scope. The legislation enhances the requirements of consent, accountability, and imposes severe punishment in case of the non-compliance of the organizations.
Though the two laws are concerned with the protection of data, they do it slightly differently. HIPAA is quite procedure-oriented and healthcare-oriented. Loi 25 is skewed towards the rights of individual privacy and executive responsibility. It has the overlap, but not the same.
Where HIPAA and Loi 25 Converge — and Diverge
At a practical level, both regulations expect companies to implement strong safeguards. Encryption, access controls, audit logs, and breach response plans are essential under either framework. Risk assessments are required. Documentation is required. Training is expected.
But Loi 25 adds requirements that might not always be front and center under HIPAA. Privacy impact assessments, for example, are mandatory in certain cases. A privacy officer must be formally designated, and by default it is the CEO unless delegated. There is also a clear push toward data minimization — collecting only what is necessary, not just what is convenient.
HIPAA, on the other hand, requires detailed administrative processes. Workforce training programs, business associate agreements, and evidence that policies are consistently followed are all crucial when pursuing HIPAA certification. Auditors don’t just want policies sitting in a folder somewhere. They want proof they are being applied.
When companies treat these two regimes separately, they often duplicate work. Two risk assessments. Two sets of documentation. Two slightly different processes for similar controls. Over time, that becomes inefficient and sometimes messy.
Automating Compliance in a Multi-Regulatory Environment
Trying to manage dual compliance manually is exhausting. Spreadsheets multiply. Policy versions get confusing. Evidence for audits is scattered across systems. Eventually, something important can slip through the cracks.
Automation changes the picture. Modern compliance tools allow organizations to map one control to multiple frameworks. For instance, a single access control policy can be aligned with HIPAA’s technical safeguards and also support Loi 25’s accountability requirements. Instead of recreating documentation, teams can centralize it.
When working toward HIPAA certification, automated evidence collection makes a noticeable difference. Logs, policy updates, user access changes — all of it can be tracked continuously instead of being assembled in a rush before an audit. The same structured system can support Loi 25 reporting and privacy impact assessments without reinventing the wheel each time.
The goal is not to treat compliance like two separate checklists. It’s to design a unified framework where controls serve multiple purposes.
Building Privacy by Design Into HealthTech Products
Even with automation, compliance cannot be an afterthought. Both HIPAA and Loi 25 increasingly expect privacy and security to be built into the system from the beginning.
For HealthTech teams, that means thinking about data minimization during feature planning. It means defaulting to least-privilege access rather than granting broad permissions. It means making sure monitoring and logging are part of backend architecture, not something bolted on later.
When privacy is embedded into product design, it becomes easier to demonstrate maturity during a HIPAA certification review. It also aligns naturally with Loi 25’s focus on executive responsibility and governance.
Of course, automation does not replace leadership. Executives still need to understand risk exposure. They still need to respond quickly when incidents happen. Technology supports accountability, but it does not eliminate it.
Competitive Advantage Through Dual Compliance
Many companies see dual compliance as a burden. And honestly, it can feel that way at first. But there is another perspective.
This is because healthcare partners in the U.S. are increasingly demanding that vendors demonstrate HIPAA certification before contracts proceed. In Canada, particularly in Quebec, organizations are getting more concerned about privacy requirements under Loi 25. The ability to clearly prove to conform to both systems can cut the duration of sales and ease in the procurement process.
Instead of slowing growth, a well-structured compliance program can actually support it. Investors also tend to view strong governance as a sign of long-term stability.
Looking Ahead
The HealthTech is changing rapidly. Remote monitoring, AI-based diagnostics, and telehealth across borders are increasing the data flow and the volume of data. The regulations will also keep changing. Greater direction, further modification, perhaps further duplication of structures.
Those companies that invest in scalable systems of compliance early (both automation and mature governance) will probably adjust more readily to whatever is next. The HIPAA certification will be crucial in the U.S. and regional regulations, such as Loi 25, will keep influencing privacy expectations in other regions.
It is not the management of either or the other one. It is about the understanding that they are intertwined. When carefully interwoven, they create a better structure, one that keeps patients safe, regulators happy and innovation moving without always leaving the hospital shaken.
Finally, compliance is not red tape. When managed well, it is the structure that ensures sustainable growth is attained.
