Key Aspects for Digital Home Monitoring Implementation

SUMMARY:

• Digital home monitoring is widely promoted to promote accessibility, efficiency and patient centered approaches to healthcare.

• Successful implementation is complex, consisting of patient, provider and health system perspectives.

• Many health systems are not yet ready to implement large scale digital home monitoring.

• Understanding and addressing the following implementation challenges are essential.

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REVIEW

Technology & Infrastructure:

• Interoperable Connected Systems

  • Digital home monitoring systems typically collect data from multiple sources

  • This usually requires the patient to use download and use multiple apps.

  • Also requires clinicians to receive multiple reports usually with different formats.

  • Most healthcare organizations use proprietary platforms which are difficult to standardize.

  • An agnostic connection device is desirable but difficult to develop.

• Stable Wide Internet Coverage

  • An established network is important for home monitoring.

  • Concerns if data transmission is interrupted.

  • Will the device store measurements and resend once connections re-established or will data be lost?

Key Considerations for Home Monitoring Implementation

 Data Accuracy and Artificial Intelligence Realization

• Incomplete data sets pose large problems for patients and providers

  • Patients forgetting to record measurements

  • Edited data of erroneous or missing data

  • Patients may stop entering measurements once stable

  • Automated reminders maybe ignored

  • Privacy concerns

• Artificial Intelligence primarily retrospective patient data

  • These models typically represent populations, not individuals

  • Algorithms should be validated

  • Liability issues persist with artificial intelligence

  • When inappropriate decisions are made.

  • Decisions based in inaccurate measurements

  • Algorithm of limited scope

  • Patient data erroneous due to device misuse.

• Avoid Clinical Data Overload

  • Clinicians do not need to be notified of irrelevant data

  • Data notification should be timely and actionable

Regulatory & Financial Context

• Proposal by CMS regarding regulation of clinical decision support algorithms

• Device-Drug Combinations have unique challenges

  • Technologies for home monitoring which span different regulatory sections:

    • Medical device

    • Software applications

    • Artificial Intelligence applications

    • Active pharmaceutical ingredients (i.e. respiratory smart inhalers)

• Financial Considerations

  • Digital devices do not always fit within traditional reimbursement pathways

  • Who will pay for the device

  • What will be covered

  • When will payment be made

  • Are cost-effectiveness models available

  • Are there reasonable budget estimates

CONCLUSIONS:

• Digital home monitoring challenges include gaps in policy, regulatory, financial and technical considerations.

• Healthcare systems should not pursue implementation of large scale digital home monitoring without understanding and addressing these implementation challenges.