Native Apps for US Healthcare

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Full Title

Status of current regulatory information on the approval of Native Apps for US Healthcare.


There are three sources of requirements for Native Apps for US Healthcare:

  1. US Cures Act Final Rule of 2020-05-01 - the regulations
  2. Medicare rules for reimbursement File:CMS-200814.pdf - the hammer behind adoption of the regulations.
  3. Trusted Exchange Framework and Common Agreement (TEFCA)
  4. FDA Medical device regulations


When the API will be required

On page 1 quote

Implement and maintain a standards-based Patient Access API: The CMS Interoperability and Patient Access final rule requires state Medicaid agencies, Medicaid managed care plans, CHIP agencies, and CHIP managed care entities to make certain health information about Medicaid and CHIP beneficiaries accessible through a Patient Access application program interface (API) by 2021-01-01. This policy enables beneficiaries to have access to their health data on their internet-enabled devices (such as smartphones). Due to the COVID-19 public health emergency (PHE), CMS is exercising enforcement discretion, however, and does not expect to enforce this requirement prior to 2021-07-01.