GDPR compliance for Health-Tech and eHealth companies

Health tech is a strictly regulated industry, in the business of processing sensitive data. This requires a high level of security and solid data practices. From fitness apps to clinical studies.

Compliance in Healthcare

Compliance in healthcare can get overwhelming, particularly when navigating ISO norms, medical device certification, HIPAA which provides a means of anonymizing data sets and the GDPR, which doesn’t. How do you know whether addressing one requirement in one framework does not violate another? Who do you call to ensure that your GDPR roadmap gets you where you want to be and that your data protection measures hold up to scrutiny?

GDPR support for Health-Tech companies

TechGDPR applies its pluridisciplinary backgrounds in technical implementations, legal expertise, quality management and learning to guarantee the steps your organization needs to bridge your compliance gaps in the most efficient way. With experience supporting developers of medical phone apps, manufacturers of medical devices, providers of operating-room solutions and clinical trials organizations, TechGDPR is your trusted partner in moving your compliance forward for you to meet release deadlines, regulatory requirements and client expectations.

While compliance is highly dependent on your company’s activities, a number of crucial points will be considered by default. Whether or not your organization is equipped with the following, our assessment will highlight, where applicable, the necessity or adequacy of these items. Detailed and prioritized recommendations pinpointing areas of improvement will reveal how you can easily bolster your compliance artifacts with or without our help, ensuring optimal processes and documentation for data subjects, clients and supervisory authorities alike.

Standard items reviewed in our assessment methodology:

  • Data categories, data points and data subject categories
  • Pseudonymisation and other technical measures
  • Access rights and other organisational measures
  • Information security and data protection training efforts
  • Policies and staff commitment to confidentiality
  • Third parties involved and the validity of international transfers
  • Inter-company agreements affecting data sharing
  • Client facing documentation
  • Product and website disclaimer compliance
  • Ability to exercise data subject rights

Common health-tech challenges for GDPR:

  • How to design a GDPR compliant clinical study?
  • How to protect medical data on user endpoints?
  • How to navigate both HIPAA and GDPR at the same time?
  • Does medical data need to be encrypted?
  • Which vendors can I use for medical data under GDPR?

We support with these and further challenges and help you with your compliance and set up for data privacy. For example under our Managed Compliance Package, or with a GDPR Compliance Project addressing the key challenges in a report.

Find out how TechGDPR can support you with eHealth/HealthTech GDPR challenges.

Request a free initial consultation