A Readiness Framework for Rural Telesurgery

Nearly one in five Americans lives in a rural area, and the hospitals serving those communities are losing surgical capability through workforce attrition, declining volumes, and closures. In many places the facility remains open while the operating room has no coverage. Telehealth expanded access to consultation without addressing this, since a patient can receive a diagnosis with no local means of acting on it. Interhospital transfer in emergency general surgery is associated with higher morbidity and mortality than direct admission.

Human telesurgery has been performed for more than two decades across multiple specialties and continents, and recent cross-border deployments have run on commercial networks with commercially available systems under real clinical and regulatory conditions.

Countries where telesurgery has progressed have treated it as a national priority rather than a technical question.

The current U.S. picture

Every component of telesurgery already falls under an agency with authority over it. FDA regulates robotic surgical systems and software. FCC and NTIA oversee spectrum, broadband, and network performance. NIST sets cybersecurity and interoperability standards. CMS and CMMI define reimbursement. HRSA, USDA, VA, and DoD support rural health infrastructure. Professional societies and accrediting bodies define clinical standards and hospital readiness. Each operates within its own mandate, and nothing requires their outputs to converge.

For this reason, what has not yet emerged is an integrated deployment framework hospitals can apply.

The hospitals with the most to gain from remote procedural support are also those least equipped to navigate fragmented requirements, operating on thin margins with limited engineering capacity.

Three readiness domains

With Omar Al Kalaa, Mischa Dohler, and Vipul Patel, I proposed a readiness framework published this year in the Journal of Robotic Surgery, organized across three interdependent domains.

Technical and safety standards. Connectivity, interoperability, and cybersecurity requirements, with defined procedures for loss of control.

Workforce, licensure, and clinical practice. Cross-state licensure for remote proceduralists, and privileging portable across institutions.

Payment, learning systems, and rural support. Reimbursement pathways for remote procedural participation.

The framework is written as operational questions, so a hospital, vendor, regulator, or society can work through it and identify gaps. Is cross-state licensure available. Are privileging requirements portable. Do bedside teams have defined procedures for connectivity loss. Are liability boundaries defined across all responsible parties.

Coordination as the near-term task

The federal government is positioned to convene agencies around cross-cutting technical questions, aligning science and technology policy across agencies whose separate actions determine whether a capability can be deployed.

Applied here, that means convening the relevant agencies alongside professional societies, establishing consensus on minimum technical, clinical, and infrastructure standards, publishing a readiness architecture hospitals and vendors can reference, and confirming that agency policies are mutually compatible. This works through existing interagency mechanisms, without new regulatory bodies or funding streams, and complements the sector-specific work each agency already does.

Coordination needs an operational counterpart. Professional societies and surgical registries already coordinate training, credentialing, and outcomes monitoring across institutions and borders, and prospective post-market structured real-world performance monitoring is feasible. These organizations can translate federal alignment into practice.

Beginning with pilots

Initial implementation should be narrow: small, well-defined pilots in hospitals that already possess peri-operative and rescue capability, using prespecified safety, reliability, and performance endpoints, coordinated through existing interagency mechanisms. These would validate the readiness criteria, test reimbursement alignment, and produce access data before wider application.

Telesurgery requires neither relocating clinicians nor consolidating facilities, extending existing capacity across distance instead. Whether that capacity reaches the communities losing it now depends on coordination rather than technology, and coordination questions resolve with leadership and urgency.

Binita S. Ashar, MD, MBA, FACS, MAMSE is a board-certified general surgeon and founder of Clarity Surgical Advisors. She served at FDA from 2000 to 2025, most recently as Office Director for Surgical and Infection Control Devices. The full framework, with Mohamad Omar Al Kalaa, Mischa Dohler, and Vipul Patel, appeared in the Journal of Robotic Surgery (2026;20:223, doi:10.1007/s11701-026-03163-5).

I consult for multiple robotic device manufacturers and serve on the board of the Society of Robotic Surgery and the Institute for Surgical Excellence. Full disclosures are published with the original article.

Manufacturer Training Programs Became Surgeon Credentialing Boundaries

Robotic harvest of the deep inferior epigastric perforator flap for breast reconstruction illustrates the problem. The dissection involves surgical planes, vessel exposure, energy use, and suturing tasks closely similar to retrorectus dissection in robotic inguinal hernia repair. Surgeons teaching robotic DIEP dissection often use inguinal hernia simulator modules to do it.

A plastic surgeon may nonetheless be unable to obtain manufacturer training for the procedure, because DIEP flap reconstruction is not listed in the device labeling.

What labeling is for

I spent 25 years at FDA, much of it responsible for the regulation of surgical robotic devices.

Device labeling describes the conditions under which a manufacturer may market a device. It reflects the procedure claims a company chose to study, submit, and seek authorization for, shaped by business considerations as much as clinical ones. Under longstanding FDA policy on industry-supported educational activities, a manufacturer cannot provide procedure-specific training outside its authorized labeling. That restriction keeps promotional activity inside the boundaries of what was reviewed, and it is appropriate.

FDA has no authority over hospital privileging. The difficulty arises downstream, where hospitals credentialing surgeons on robotic platforms borrowed manufacturer training courses as their standard. When robotic surgery was unfamiliar and one platform dominated, the manufacturer had the only curriculum and the shortcut made sense.

A boundary drawn around what a company may promote now functions as the boundary of what a surgeon may be trained and privileged to do.

Why now

There are multiple authorized platforms. Residents complete training with substantial robotic experience and documented milestones. Procedures across specialties share anatomy, planes, and maneuvers.

Criteria also vary from institution to institution. Surgeons with privileges at several hospitals routinely describe meeting different robotic requirements at each one. Where standards are set locally against no common reference, demonstrated competence does not travel with the surgeon, and manufacturer courses were at least uniform.

Surgeons excluded by this are already qualified within their specialty. The barrier reflects administrative policy rather than patient risk.

A competency-based alternative

Jesse Selber and I proposed a vendor-neutral, competency-based model in JAMA Surgery this year. It has four parts.

Multiple equivalent on-ramps. Residency and fellowship robotic milestones, society-accredited curricula, independent simulator benchmarks, and documented proctoring all count toward entry. Manufacturer courses become one route among several.

Procedure-agnostic platform safety training. Setup, docking, energy safety, troubleshooting, emergency undocking. This material does not transfer between systems, and manufacturers are well positioned to teach it. Delivered without reference to specific procedures, it remains nonpromotional.

Privileges granted by anatomical domain. Abdominal wall, breast, foregut, transoral, rather than by labeled procedure names. Initial privileges require the safety course, simulator benchmarks, and proctored cases. Maintenance pairs modest annual volume with Ongoing Professional Practice Evaluation, which accredited hospitals already run.

Outcomes assessed with clear denominators. Conversions, complications, reoperations, length of stay, follow-up, and procedure-specific end points, reviewed at intervals by a cross-specialty committee, with predefined triggers for focused review, additional proctoring, or retraining.

This applies to established platforms and procedures with well-characterized risks. Novel platforms, newly enabled procedures, and major device iterations should continue to follow labeled onboarding and vendor-specific training until safety competencies are defined, specialty credentialing boundaries are unchanged, and manufacturer involvement continues in nonpromotional, specialty-agnostic form.

In practice

This model has been implemented at two academic centers, for abdominal-wall and retrorectus procedures, selected reconstructive procedures, and transoral procedures.

Any hospital can adopt it now, with no regulatory change, no new FDA authority, and no legislation. It requires a credentialing committee to decide that its robotic privileging criteria should measure competence rather than course completion.

Course completion is easy to document and competence is harder to assess. That is why the shortcut has lasted, and it is not sufficient reason to keep it.

Binita S. Ashar, MD, MBA, FACS, MAMSE is a board-certified general surgeon and founder of Clarity Surgical Advisors. She served at FDA from 2000 to 2025, most recently as Office Director for Surgical and Infection Control Devices. The full paper, with Jesse C. Selber, MD, MPH, MHCM, appeared in JAMA Surgery on May 13, 2026 (doi:10.1001/jamasurg.2026.1350).

I consult for multiple robotic device manufacturers. Full disclosures are published with the original article in JAMA Surgery.

Alignment Across Evidence, Labeling, and Clinical Use

FDA review of surgical devices often exposes misalignment among clinical evidence, intended claims, labeling, workflow, and real-world use.

Each element may appear reasonable in isolation. The full program may not.

The clinical study may support one use case while the proposed labeling describes another. The trial setting may not reflect community practice. The regulatory pathway may assume clinical consensus that does not exist. Product-risk controls may not account for how users actually interact with the device.

Early signals often appear as FDA questions that do not fit the team’s precedent analysis, concerns from clinical staff, or disagreement between regulatory and commercial teams.

Once these issues are embedded in a submission, resolution usually requires more time and evidence. Earlier review can identify the mismatch while study design, claims, labeling, and risk controls can still be changed.

Independent review is most useful at these decision points: before the evidence plan is fixed, before an FDA meeting, or when the team cannot reconcile the agency’s feedback with its existing strategy.

When Regulatory Precedent Is Not Enough

The most experienced regulatory teams know how to read precedent. They know which predicates were accepted, how FDA has historically evaluated similar technologies, and which arguments have worked before.

That expertise matters. In surgical robotics, aesthetic and reconstructive devices, and other technologies whose performance depends on workflow, user technique, software, or clinical context, precedent is only a starting point.

These products may not fit cleanly into what came before. The comparator may be imperfect. The endpoint may not capture what matters in use. The failure modes may differ from those of prior devices. FDA’s questions may concern the product’s actual clinical setting rather than what was accepted previously.

The resulting problems are predictable: questions the team did not anticipate, requests for data that do not follow precedent, or late recognition that the evidence and clinical use were not aligned.

Companies navigate these issues by evaluating the specific device, claims, users, risks, and clinical setting rather than relying only on prior submissions.

For new technologies, precedent informs the analysis. It does not complete it.