Presenters Details: Saul Jankelow Title of Presenta5on: So6ware as a medical device Date: 24 August 2017
So#ware as a medical device (SaMD) So6ware has become cri5cally important in the efficient running of any modern prac5ce. So6ware as a Medical Device is commonly defined as so6ware that is designed for a medical purpose, and that is not part of an actual medical hardware device. In general, regula5ons address health risks of so6ware that is embedded in a tradi5onal medical device, however the applica5on of these controls may not address the risks posed by SaMD, or assure appropriate protec5on of pa5ent informa5on, compliance to regula5ons like HIPAA in the US, POPI in S.A for example. It is cri5cal that so6ware is developed, tested and con5nuously monitored to ensure that risks are minimized in terms of business, financial impact on the prac5ce, and clinically to the pa5ent.
Our so6ware is evaluated by Microso6 to ensure that we comply with best prac5ce so6ware design, and Microso6 survey our clients con5nuously to ensure compliance. The development of medical so6ware - no marer if designed for embedded hardware devices or PC s such as diagnosis or therapy planning systems - is controlled by the interna5onal IEC 62304 standard. This norm sets rules for all steps in the lifecycle of medical so6ware (ref hrps://en.wikipedia.org/wiki/iec_62304) to which we comply with. One of our managing partners is a prac5cing den5st, and together with a select set of clinicians, (Cardiologist, Physician, Radiologist and GP), we have a con5nuous forum to discuss, design and ensure the sensible approach to our interface and working of the so6ware. We try to always approach our design from the clinician and admin staff s point of view, rather than a programmer s!
Disciplines and Doctors SOLUMED has been around since 1987, founded by Dr Peter Noach. Approx. 2 500 prac5ces in South Africa, and Africa across all dental, medical, radiology and allied prac5ces, veterinary live since 2017. AVANTedge group (Microso6 Gold partner) took majority stake in 2008, we have a staff of 80 people (including R&D of 25 developers), head office in Johannesburg, and an office in Cape Town. Redeveloped new modern system, live for last 6 years. Modern MS Outlook look and feel. Cloud based tariff updater, auto load tariffs from all co-opera5ng medical schemes. Modern robust database (Microso6 SQL Server), web enabled technology. Work with all switching houses, prefer Mediswitch Online for the 5me being. EMR system, arach anything to pa5ent record, integrated pathology results, template report authoring.
Some features Integrated RIS(Radiology Informa5on System) with our prac5ce management and Billing, DICOM MWL, full HL7 services, integra5on with HIS systems. Workflow so6ware in front of billing so6ware for any medical prac5ce. (DHC) Easy to use diary with integra5on to an online diary/prac5ce presence with partner company Recomed (www.recomed.co.za) Easy capture of pa5ent accounts, and dependants MSV (Member Status Valida5on) auto populate, deduplica5on. Billing is quick and easy, either by procedure code, or lookup by descrip5on. Macro/ shortcuts used to increase efficiency. Easy 5e-up between the ICD10 used in billing (for the transac5on) and the clinical note. Integra5on of SMS, and email to increase effec5ve pa5ent communica5on, easily communicate appointment reminders, thank you SMS for payment, reminders regarding outstanding balances.
Integrated EMR and Billing Our integrated EMR allows for unlimited report templates, for quick repor5ng and electronic storage of the reports, with unlimited field defini5on (text, number, date, lookup). Integra5on with devices such as Echo, ECG to easily obtain data and store to the pa5ent. Also drag and drop arachments from PC, or email. Acquire from Scanner Pathology results integrated from Lancet, Ampath and Pathcare (Sep 2017). Easy way to associate results to the pa5ent easily, tabular comparison of specific results over 5me. SMS integra5on to alert the pa5ent that results are available, we do NOT send results though. Easy to use searching for clinical and/or marke5ng purposes Any combina5on of Age, Gender, ICD10 codes, Procedure codes, Defined fields in EMR templates. Example: Mammo, prostate reminder, dental, research for drug trial)
What's next for Solumed? Web/mobile based system to free up the Doctor from the desk. Walk around the prac5ce and/or hospital as long as there is Wi-Fi/internet to connect to prac5ce server. Review ward round list, easily find pa5ents records, add notes, dictate, create reports based on the templates, email to referring or referred to doctors, take photos from iphone, ipad, Android devices, arachments land up in EMR automa5cally. Send ac5vity to WIP (Work in Progress) so admin ensures appropriate billing is done correctly. By mid 2018, complete cloud based func5onality to run the prac5ce on or off premise with no so6ware needed to be installed.
What's next for Solumed? Web/mobile based system to free up the Doctor from the desk. Review ward round list, easily find pa5ents records, add notes, dictate, take photos from iphone, ipad, Android devices, arachments land up in EMR automa5cally. Send ac5vity to WIP (Work in Progress) so admin ensures appropriate billing is done correctly. By mid 2018, complete cloud based func5onality to run the prac5ce on or off premise. Integra5on with Medical robots with HL7 messaging
What's next for Solumed? Telehealth solu5ons - Integra5on with Medical robots via exis5ng HL7 messaging. We have a 5e up with the African distributor of US based robots to integrate into billing and EMR (via HL7 services).
Q & A Thank you!