Table 1.

HEARTS in the Americas: recommendations toward the exclusive use of clinically validated, automated BPMDs.

Recommendations	Description
Early adoption strategy	The government acts to regulate the market instead of waiting for voluntary measures by the manufacturers and distributors (self-regulation). This strategy may motivate the industry to promote BPMDs that have been validated and thus use them as a marketing strategy, generating a win-win situation.
Gradual implementation	To facilitate acceptance and provide time for a realistic substitution of automatic validated BPMDs, including avoiding high costs, preventing challenges by manufacturers and distributors, regulations must be designed to allow for implementation over time. A grace period for procurement may help in that process.
Timeframe	Establishing a timeframe to debate and adopt the regulation, and fully implement it may reduce the potential for the regulation lagging. Defining a specific timeframe helps identify the goals and comply with the commitments of the parties involved.
Flexibility	It may be hard to change medical devices laws, but the regulation must be flexible to allow for modifications and adjustments as needed. New standards for accuracy validation and other scientific evidence, when available, must be incorporated swiftly to increase its effectiveness. A system to recognize standards faster than modifying regulations should be adopted to include a rapid revision of international standards.
Sustainability	Regulation must be a component of a national health plan and strategy for NCD, cardiovascular health/hypertension, and medical devices laws.
Monitoring and evaluation	To measure the impact of the implementation of a regulatory framework and correct its course, the implementation should be monitored and evaluated. This process must be linked to the procurement of BPMDs for use in primary health care facilities. HEARTS system for monitoring and evaluation already includes BPMDs and certification to BP measurement among its indicators.
Enforcement	Mechanisms, roles of responsible government bodies, and budget for monitoring and enforcement of compliance, including sanctions, need to be defined. In addition, coordination with other government sectors (e.g., Trade, Customs) must be set in place, mainly since most BPMDs are imported into the Americas.