Digital medicine, mobile health apps, and other means of patient monitoring and the provision of treatment and health care advice remotely via technology quickly became primary means of communication between patients and health care providers during the COVID-19 pandemic. The accelerated shift to mobile health has accentuated privacy and data security challenges in the development of telemedicine programs, patient wearables, and other Internet of Medical Things (IoMT) solutions.

These medical devices can be vulnerable to cybersecurity attacks and breaches just like other computer systems. Because these attacks can impact the safety and effectiveness of the devices as well as revealing patients’ sensitive personal information, regulators are monitoring the development of mobile health offerings. For example, the Food and Drug Administration (FDA) encourages manufacturers of medical devices, hospitals, and facilities to work together to manage cybersecurity risks.

So that your organization can stay on track with privacy and data security compliance, our attorneys can assist with the issues you face:

  • Increasingly rigorous privacy and security standards and requirements.
  • Rapidly evolving data security threat landscape.
  • New products, either in-house or third party.
  • Physical and end-to-end security issues.
  • Secure integration with other tools and platforms.
  • Heightened consumer, patient, and user privacy expectations.
  • Safeguards to avoid improper influence over professional medical decision-making.

Our attorneys can also provide services including:

  • Product development (privacy and security by design).
  • Privacy and security compliance review for tele-applications, including gap analysis and benchmarking, and information security assessment and presentment for ongoing issues in the field.
  • Compliance policies and procedures.
  • Internal training via tabletop and virtual simulated exercises.
  • Contract negotiations.

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