Medtech companies leveraging data must meet FDA and compliance-related requirements, especially given evolving laws and social concerns.
Here are the top 5 compliance issues for medtech-enabled data platforms:
Medtech companies should be particularly mindful of the following legal and regulatory compliance issues:
1. Data Collection, Use and Sharing
Medtech-enabled data platform companies need to be mindful to take appropriate care of data, including:
- Patient data
- Drug development data
- Customer/provider data
- AI/ML-developed data sets
Companies should prioritize the following for any data collection, use and sharing:
2. Adapting to Evolving Interactions with Physicians, Patients and Other Stakeholders
- As the landscape moves from a treatment/provider-centric approach to a preventive/patient-centric one, interactions with patients present a host of additional compliance issues.
- Company relationships with healthcare providers and customers are changing, especially as technology allows for greater real-time monitoring of patients and real-time data entry.
- Enhanced data collection means increased collaboration with stakeholders.
3. New Regulatory Regimes Around Donation of EHR, Cybersecurity Technology and Information Blocking
- As HHS implements new regulatory requirements around topics like the donation of EHR & cybersecurity technology, companies needs to be mindful of tracking these donations and transparency requirements, ensuring that each arrangement is supported by legitimate need and addressing topics like updates and replacements.
- New rules on information blocking and defined standards of “interoperability” could have an impact on medtech-enabled data platforms.
4. Addressing value-based care considerations and the federal anti-kickback statute safe harbors
Medtech-enabled data platform opportunities include: (i) streamlining and coordinating care, (ii) real-time quality and outcomes measurement, (iii) more narrowly tailored, patient-centric solutions, (iv) enhanced data view when coupled with machine learning, and (v) cost savings. However, companies should carefully examine federal Anti-Kickback Statute safe harbors and align their practices to these regulatory requirements.
5. Navigating through the lack of advanced industry standards
Medtech-enabled data platforms reflect a new evolution in the medtech industry, and there is a need for more advanced industry compliance standards beyond the typical topics addressed by industry codes of ethics, like the AdvaMed Code of Ethics. While codes currently focus on traditional sales and commercial arrangements, a growing industry requires new industry-wide thinking on topics like the ethics of data and AI, data sharing among companies and with customers and information blocking.