[1] 冯惠春,郑香琴,王黎红,等. 肺癌患者“放疗助手”APP健康教育效果评价[J]. 预防医学,2019,31(1):140-143. [2] 韩辰宇,钱进,金海英,等. 移动医疗APP对门诊2型糖尿病患者治疗效果评价[J]. 上海预防医学,2019,31(1):64-69. [3] 张子豪,章红英. 健康管理类应用软件国内外现状与前景分析[J]. 中国中医药图书情报杂志,2015,39(6):8-12. [4] KING J.Building a mobile medical APP and understanding FDA regulatory requirements[J]. Biomed Instrum Technol, 2015, 49(2): 99-104. [5] Guidance(n.d). Mobile health market report2013-2017[R/OL]. [2019-01-02]. https://research2guidance.com/wp-content/uploads/ 2015/08/Mobile-Health-Market-Report-2013-2017-Preview.pdf . [6] ELAVSKY S,SMAHEL D,MACHACKOVA H.Who are mobile app users from healthy lifestyle websites? Analysis of patterns of app use and user characteristics[J]. Transl Behav Med,2017,7(4):891-901. [7] DALTON J A,RODGER D,WILMORE M,et al.The Health-e Babies App for antenatal education:feasibility for socially disadvantaged women[J]. PLoS One,2018,13(5):e0194337. [8] OZDALGA E,OZDALGA A,AHUJA N.The smartphone in medicine:a review of current and potential use among physicians and students[J]. J Med Internet Res,2012,14(5):e128. [9] SCLAFANI J,TIRRELL T F,FRANKO O I.Mobile tablet use among academic physicians and trainees[J]. J Med Syst,2013,37(1):9903. [10] 赵列宾,陈宇红,董斌. 基于互联网及全科-专科合作的社区糖尿病管理模式——上海五里桥试验[J]. 中华内分泌代谢杂志,2012,28(4):208-289. [11] DONKER T,PETRIE K,PROUDFOOT J,et al.Smartphones for smarter delivery of mental health programs:a systematic review[J]. J Med Internet Res,2013,15(11):e247. [12] CARTER M C,BURLEY V J,NYKJAER C,et al.Adherence to a smartphone application for weight loss compared to website and paper diary:pilot randomized controlled trial[J]. J Med Internet Res,2013,15(4):e32. [13] Draft guidance for Industry and Food and Drug Administration staff,mobile medical application draft guidance[R].mobile medical application draft guidance[R].2011. [14] Guidance for Industry and FDA staff,guidance for the content of premarket submissions for software contained in medical devices[R].guidance for the content of premarket submissions for software contained in medical devices[R]. 2005. [15] CENSI F,MATTEI E,TRIVENTI M,et al.Regulatory frameworks for mobile medical applications Expert Rev[J]. Med Devices,2015,12(3):273-278 . [16] European Parliament and Council. Directive 2007/47/EC,amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices,Council[R].2007. [17] Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market[M]. Official Journal of the European Union,L Series,2007,247:21-55 . [18] European Parliament and Council. Directive 95/46/EC on the protection of individuals with regard to the processing of personal data and on the free movement of such data[M]. Official Journal L Series,1995,281:31-50 . [19] Food and Drug Administration. Medical Devices,Current Good Manufacturing Practice(CGMP)Final Rule,Quality System Regulation[R]. [20] LEWIS T L,WYATT J C. mHealth and mobile medical Apps: a framework to assess risk and promote safer use[J]. J Med Internet Res,2014,16(9):e210. [21] 贾承安. 网络安全风险评估关键技术研究[J]. 网络安全技术与应用,2018(10):12-13. [22] 张钟仪. 医院网络安全风险与防范方式分析[J]. 科学信息化,2018(33):147. |