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A regulatory framework emerges for digital medicine

Nature Biotechnology volume 33, pages 697–702 (2015)Cite this article

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Clear and logical regulatory guidelines on the process and requirements for approval of health apps and wearable sensors will be essential for the digital medicine sector to unleash its full potential.

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References

  1. Medical Device Data Systems Final Rule, 76 FR 8637 FDA (2011).

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Authors and Affiliations

  1. Eric Elenko & Daphne Zohar are at PureTech, Boston, Massachusetts, USA.,

    Eric Elenko & Daphne Zohar

  2. Austin Speier is at Precision for Medicine, Bethesda, Maryland, USA.,

    Austin Speier

Authors
  1. Eric Elenko
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  2. Austin Speier
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  3. Daphne Zohar
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Corresponding author

Correspondence to Daphne Zohar.

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Competing interests

PureTech is actively forming companies in the digital medicine area, including Akili, which is mentioned in the article.

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Elenko, E., Speier, A. & Zohar, D. A regulatory framework emerges for digital medicine. Nat Biotechnol 33, 697–702 (2015). https://doi.org/10.1038/nbt.3284

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