RWE: Better Research Demands Better Privacy

This is the second in a five-part blog series focusing on how life sciences companies can establish leadership in the field of real-world evidence.

Increasing leverage of electronic health records (EHRs), imaging systems and social media is delivering groundbreaking patient-centric insight like never before. But as companies seek deeper understanding of health outcomes via patient-level data, privacy-enhancing capabilities are becoming not only an imperative but also a critical source of leadership. These same capabilities are key to unlocking the full value of real-world evidence (RWE).

In our last blog post, we introduced four considerations that life sciences companies should keep top of mind when building an RWE ecosystem:

  1. Better research demands better privacy
  2. Greater RWE sophistication, greater privacy consideration
  3. From blunt tools to risk-based privacy techniques
  4. Extended opportunities from privacy leadership in RWE

Today’s post focuses on consideration number one – better research demands better privacy.

Secondary use of individual-level patient data for health research has unparalleled potential to improve healthcare quality and drive medicines innovation, benefiting individual patients and society as a whole. To optimize its value for scientific research and meet tightening privacy regulations, there is a pressing need for a systematic approach to privacy management and de-identification of data. Life sciences companies can take a lead in implementing best practice using risk-based privacy enhancing techniques.

Levering patient-level Protected Health Information (PHI) is essential for scientific research. Originating from various sources, including EHRs, PHI plays a vital role in the development of innovative medicines and improvement of health system performance. A number of high profile initiatives, including PCORI in the USA and , seek to maximize this potential – a point underscored by the American Society of Clinical Oncology (ASCO): “When trial data inform our decisions, we tap into only 3% of the cancer patient population.…To improve care for every patient, we need insights from the other 97% of people receiving cancer care.”

The ethical and moral case for facilitating the use of PHI for research and the overall benefit of society is compelling, even without consent which is often not practical to obtain. Various regulations, from HIPAA in the USA to the recent changes in European data protection law, recognize this, and data may be utilized without explicit consent when in the public interest.

Additionally, public attitudes, especially among individuals with higher awareness and understanding of EHRs, are supportive of use without explicit consent via de-identified records.

However, two barriers exist to effectively de-identify data. First, there is ambiguity in data protection regulations in selected countries, and even when clear, these are not always implemented in a systematic and apolitical Second, the de-identification approaches applied need to avoid destroying the value of the data for research. Both of these challenges may best be addressed through capabilities in information technology, which now exist at global scale.

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